The success of the generic firm can be distilled into the realization of three aspirations: One, bring high value new products to market first; Two, deliver products to the customer with market leading service levels and three, manufacture products with competitive COGS (Cost of Goods Sold) The firm that consistently develops and executes strategies to achieve these three goals will survive and thrive in the generic business.
Sourcing of APIs (Active Pharmaceutical Ingredients) has a crucial role to play in realizing these aspirations.
1. Bring high value new products to market first
The availability of suitable APIs frequently determines when new product development can start. Consequently the firm that is first to create a source of a previously unavailable API is best positioned to bring the new generic product to market first.
2. Deliver product to the customer with market leading service levels
Production of API is typically the most technically complex element of the pharmaceutical supply chain. The cycle-time from purchasing of basic chemicals to delivery of finished API can range from months to greater than one year. The generic firm must deliver product to its customers within lead-times measured in days. The API supply chain strategy is critical to successfully realizing these customer service aspirations.
3. Manufacture products with competitive COGS
The API cost contributes typically 45-50% of COGS for oral solid dosage products. Management of API cost is essential to maintaining a competitive cost structure. During the development of the generic product, the cost of API is frequently the largest single expense in the total development cost. Tight control of the API cost is required to keep product development expenses competitive.
This article details how the API sourcing manager can develop strategies and tactics to drive success for the generic firm.
New Product Opportunity Identification
Traditionally, API sourcing worked by taking a list of new products selected for development and searching for manufacturers who developed the API required for these new products. As mentioned, the sourcing of API is frequently the critical path for the timing of bringing a new generic product to market. It is essential at the outset, therefore, that the API sourcing manager uses his expertise to provide upfront input into the new product selection process. The process must highlight those products where high barriers to sourcing the API exist. These barriers can be derived from complex technology required to produce the API, significant capital investment needed to manufacture the anticipated volumes or intellectual property that must be designed around to bring a non-infringing product to market. Hand in hand with applying expertise to identify these opportunities, the sourcing manager must develop relationships and partnerships with API manufacturers that can overcome these barriers to entry. To add value in this role, the sourcing manager must continuously develop a broad understanding of trends in the pharmaceuticals market, API technology, intellectual property, GMP and EHS regulations.
API Sourcing Strategy Preparation
Once the new product opportunity has been identified, API sourcing is critical to successful development of the product. Several criteria must be assessed to prepare a successful sourcing strategy. It is important to note that this is a continuous process from new project selection to the late stages of the product lifecycle. All elements of the strategy must be continuously updated to factor in changes in the operating environment.
The following inputs to the preparation of the sourcing strategy will be discussed:
• Potential show stoppers;
• GMP compliance;
• EHS compliance and good corporate citizenship;
• Patent strategy;
• Product quality;
• Quality specifications and analytical methods
• DMF review management;
• Supply chain;
• API supply chain evaluation;
• Launch management;
• Cost;
• API cost drivers;
• Strategies for maintaining cost competitiveness and
• Multiple source qualification strategy
Potential Show-Stoppers
Potential show-stoppers are elements of the sourcing strategy where a failure has the potential to put the generic firm and the API manufacturer out of the business. Show-stoppers include the issues detailed here.
GMP Compliance: GMP compliance of the API manufacturer is paramount. A failure of GMP compliance is a show-stopper for both API suppliers and generic pharma. The sourcing manager must facilitate the assessment of GMP compliance of the API supplier by the generic firm’s QA function. The assessment of GMP compliance must be made as early as possible in the product development process and most certainly prior to ordering the API needed to manufacture the registration batch. Beyond this point, if a GMP deficiency is found at the API manufacturer, the approval of the generic firm’s new product will be significantly delayed.
Written evidence of satisfactory inspections of the API manufacturer’s facility are acceptable as a leading indicator of GMP compliance only if they are from the same regulatory authorities which will review the generic firm’s new product application. The facility inspected must have been the same facility that will manufacture the API in question and the inspection must have occurred no more than 18 months prior to the date when the generic firm expects to submit the new product application. This evidence of successful inspection should not replace the audit of the facility by the generic firm’s QA team.
If the generic firm is submitting an ANDA to the U.S. FDA, the sourcing manager and the API manufacturer should assume that the FDA will require a prior approval inspection of the manufacturing facility. If the API manufacturer’s facility was recently inspected by the FDA, it is possible that the requirement for a prior approval inspection will be waived.
In some cases, it is critical to select a supplier that is most likely to have the PAI requirement waived. This is particularly important in the U.S. for ANDA applications submitted to FDA on the NCE expiration date when no unexpired patents are listed in the Orange Book. In these cases, the generic firm can launch the product immediately upon approval of the application. Therefore, if a pre-approval-inspection (PAI) is not required at the API manufacturer’s facility, a significant period of time is eliminated from the review of the ANDA.
In order to be the first generic firm to bring the new product to market, it is sometimes necessary to start development of the new product using API from a manufacturer who does not meet all GMP compliance requirements. This can be the case when the technology required to produce the API is available immediately only from a non-GMP manufacturer. In this case the sourcing manager must build the business case for investment in assisting the API manufacturer to upgrade the GMP standards at the facility to comply with the minimum acceptable standard (ICH Q7A). In all cases, the API manufacturer must be 100% GMP compliant before starting production of the registration batches of API.
EHS Compliance and Corporate Citizenship
The reputation of a generic pharmaceutical firm is an extremely valuable asset. It takes years to build, yet can be destroyed in minutes. It is incumbent upon the generic firm to make sure that the highest standards of good corporate citizenship and environmental health and safety are met by all its suppliers. The standards that the generic firm demands of its suppliers must be consistent with the highest standards that it sets for its own operations, regardless of the particular regulations governing the location of the supplier.
Patent Strategy
The development of the generic pharmaceutical market is derived directly from the discovery, development, approval and marketing of new drugs by the discovery led pharmaceutical industry, a.k.a. “Brand Pharma.” It is common to hear the missions of Brand Pharma and Generic Pharma described in terms of being polar opposites in their benefits to the patient. I believe that the tension between the two produces a symbiotic relationship that is healthy for the patient. The patent system creates the legal structure to reward the discovery of innovative drugs with a defined monopoly period in which the inventor can justifiably recoup the enormous investment made to bring the new drug to market. The tenacious efforts of the generic pharma industry to bring bio-equivalent products to market at the earliest opportunity without infringing upon the intellectual property of the inventor generates a stimulus for further innovation in new drug development. Indeed, the generic pharma industry was once famously described as not being a subset of the pharmaceutical business but of the patent litigation business.
The subject of the generic firm’s development of an intellectual property strategy to successfully bring a new generic to market at the earliest opportunity is enormous in scope and fundamentally important to the existence and success of the generic firm. This article however will focus only on the basic due diligence steps that the sourcing manager must complete in order to ensure that the API source selected is suitable to take forward in development of the firm’s generic product. Detailed guidance and final patent strategy approval must be driven by the firm’s patent department.
The earliest opportunity for the generic firm to bring a new product to market is typically upon expiration in that market of the product patent claiming the chemical structure of the API. However, in some cases, generic firms will challenge the validity of the patent in an attempt to bring their bioequivalent product to market sooner. In addition to the grant of a product patent claiming the chemical structure of the API, the brand pharma company will develop a portfolio of intellectual property related to other innovative aspects of the new drug. Of most significance to the sourcing manager are patents claiming modifications of the API or processes to manufacture the API.
An essential part of the API sourcing strategy development is the assessment of the potential suppliers' product and process against the claims of all patents relevant to the production or sale of the API, or products manufactured by the generic firm using the API. Regardless of the provision of statements of non-infringement by the API manufacturer, it is essential that the generic firm assures itself first-hand that no valid patents are infringed by the API supplier. This presents a conflict between the sourcing manager’s need to complete intellectual property due diligence and the API manufacturer’s right to protect his proprietary information. A number of approaches are possible to overcome this conflict and to satisfy the needs of both parties.
The simplest approach is to execute a Confidential Disclosure Agreement between the parties that clearly outlines the terms under which the information is to be exchanged, including the limitations on who within the generic firm can use the supplier’s information and how they can use it. This approach facilitates the greatest transparency between the sourcing manager and the API supplier while protecting the latter’s interests. A second approach is to exchange the process and product information directly and confidentially between the patent attorneys of the API manufacturer and the generic firm. This has the advantage of maintaining the greatest level of confidentiality of the API manufacturer’s proprietary information; however, it limits the sourcing manager's understanding of the supplier’s strategy.
The primary focus of patent due diligence is on the intellectual property owned by the inventor or marketer of the drug. In recent years, the level of patent application activity by both API manufacturers and generic firms has increased exponentially. The strategy behind this increase in activity can be described as both defensive and offensive (but is primarily defensive).
Developing a New Product
The traditional and simplest approach that the API manufacturer can take when developing a new product is to follow a prior-art process from the literature or from an example described in the product patent specification itself. However, this is not always the most practical solution. The prior-art process technology by definition is more than 20 years old and may not be suitable for many reasons, including economics, product quality or environmental, health and safety reasons. If this is the case, the API firm must develop an alternative solution. As mentioned, the primary motivation for the API supplier or generic firm to submit patent applications claiming the technology used to produce their products is as a defensive strategy. It is in the firm’s best interest to ensure “freedom-to-operate” the process or product developed. This can be accomplished by submitting a patent application claiming the invention. The submission of the patent will create a priority date and in most cases result in the publication of the application. Assuming that another firm has not previously discovered the invention and submitted a patent application, the submission of the patent could protect the API firm from being blocked from operating the technology if a competitor subsequently files a patent.
An offensive patent strategy could be adopted when the generic firm or API manufacturer believes the novel process or product that enables them to bring the generic product to market is the only option to overcome barriers to entry. If the patent application is granted, it can be used to prevent other generic firms from using the same invention to bring a generic product to market before the expiration date. The level of litigation between generic firms has been slowly increasing in recent years and can be expected to increase over time to the extent that the future could bring as much litigation between generic firms as between brand pharma and generic firms.
The increase in patent application activity is most pronounced in the field of polymorphism. To the layperson, the explosion of creativity is dazzling. In some cases applications have been published for more than 40 different polymorphic forms of the same API.
Once again, the simplest strategy is to manufacture a prior-art form and demonstrate satisfactorily that the same form is produced consistently with no contamination of other forms and no conversion to other forms during processing or during stability studies. It is critical that the sourcing manager leads a joint working group between his generic firm and the API manufacturer to agree on the specifications and methods to be filed describing polymorphism of the API.
The deepening of understanding of polymorphism on the performance of drug products continues to have a major impact on the evolution of regulations governing the approval of new drug applications. This is a subject that must be followed closely by the sourcing manager and factored into his strategy with the expert advice of his regulatory affairs, patent and development colleagues.
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Finally, development of a generic product using a different physical form than that used by the brand company to manufacture the reference product presents a challenge to the formulation development team. Different crystal forms will possess different solubility properties and therefore different bioavailability properties. The formulation scientist must overcome the challenge of designing the formulation to match the bioavailability of the brand product.
Ensuring Product Quality
When it comes to setting the specifications for API and comparing quality of materials from different sources, the days of “better than USP” are long gone. ICH guidelines for related compounds and residual solvents describe the minimum standards to which API quality must comply. Throughout the development process the sourcing manager must ensure that the quality of API produced by the potential manufacturer meets these minimum standards.
The analytical R&D must analyze materials from potential suppliers. Sourcing and the analytical team must assess the results to determine:
(a) if the materials supplied currently meet the quality requirements and, more importantly,
(b) if the supplier has completed the studies required to implement adequate controls to ensure that the materials produced in the future will consistently meet the quality requirements.
Stressed stability studies and process stressing studies should be carried out. All potential related compounds should be characterized, if possible. Analytical methods should be capable of detecting all potential related compounds. The sourcing manager should never be over-confident due to an ultra-pure sample prepared in the API manufacturer's process development laboratory.
Effective coordination of specifications and analytical methods between the suppliers DMF and the generic firms application can have the greatest impact on reducing product approval times and eliminating potential for problems later in the project. The sourcing manager must involve his analytical R&D and regulatory affairs teams early in the process to reach agreement with the supplier on the API specifications and the methods of analysis. In the ideal situation, the same specifications and methods should be used by the supplier and the generic firm. However, this is not always possible. It is critical that a clear understanding is reached on the comparability of results between the two companies' methods. In all cases, the final decision on material suitability will be made based on the generic firm’s analysis. To eliminate the potential for rejection of batches, the supplier should understand the comparability of results reported using his own methods and that of the generic firm. This is particularly important in the case of the physical property specifications.
During development it is good practice to sample API lots with the widest possible range of particle size distributions to get a broad view of the impact that particle size has on formulation performance. Thereafter, when purchasing the API to manufacture the registration batches, the specific API lot used to complete development of the formulation should be requested. If the formulator needs to re-size the lots received to prepare formulation process trials, it will not be possible to get an exact match for the registration batch. It is absolutely critical during the development process that the sourcing manager clearly communicates all quality requirements-particularly the physical property requirements-to the API manufacturer. The quality requirements should be incorporated as a detailed condition in the purchase order.
DMF Review Management
During the review of the generic firm’s new product application, the authorities will in parallel review the DMF submitted by the API manufacturer. It is not uncommon for the reviewer to issue a written request to the DMF holder requesting a response to deficiencies in the DMF. It is critically important that the sourcing manager maintains efficient communication with the API manufacturer regarding the receipt and response to DMF deficiencies. The manufacturer should clearly understand the need to immediately notify the sourcing manager upon receipt of the deficiency letter. Although it is not required of the manufacturer, depending upon the level of trust between the two firms, it is helpful if the details of the deficiencies cited are shared with the generic firm. The sourcing manager should lead a working group consisting of the representatives from the generic firm’s regulatory affairs and development teams and the API manufacturer with the objective of coordinating their responses to the deficiency letter. Changes in specifications and/or analytical methods must be coordinated between the two firms to ensure the responses don’t create a conflict.
Effective coordination of the quality specifications and analytical methods filed in the generic firm’s new product application and API manufacturer’s DMF will minimize the potential for deficiencies. If the reviewer cites deficiencies, effective coordination between the two firms will reduce the review period and minimize the potential for further follow-up questions after the responses are submitted.
Before filing a new product application, a full understanding of the API manufacturer’s process scale-up plans is essential—any plan must be discussed by the sourcing manager’s regulatory affairs team and the API manufacturer’s process development and regulatory affairs teams. Requirements for supporting data, documentation and notifications to the authorities should be agreed upon upfront.
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Supply Chain Evaluations
Customer service is a critical success factor for the generic firm's business. In the generic operating environment, timing and extent of customer demand is volatile. Sophisticated supply chain management strategies are essential to successfully delivering product , monitoring strong customer relationships and minimizing working capital. The API supply chain is significantly more complex than that of other raw materials and components used in the manufacture of the generic firm’s product; therefore specific supply chain management processes are needed for APIs.
The sourcing manager must evaluate the strength of potential API supplier’s supply chain when selecting a source during the new product development phase. To do this, an approximation of the new product launch window and API demand is needed. This must be prepared with the input of a number of expert groups within the firm including, the patent department, sales and marketing, regulatory affairs, manufacturing and project/launch management. In most cases the selection of the API source to be included in the new product application is made years prior to the earliest potential launch date, while the degree of accuracy possible when estimating launch timing and demand is low. It is essential to begin early in the product development phase to outline a range of market demand scenarios (with probabilities of occurrence) and to continually adjust the plan as new information is obtained.
When evaluating the potential API suppliers’ ability to support the generic firm’s demand, the sourcing manager must evaluate several criteria:
| 1. | Manufacturing process |
| A. | From what point in the synthetic route is the API supplier starting the manufacturing process? |
| B. | Is the supplier back-integrated to basic chemical starting materials? |
| C. | If so, what is the strategic benefit of back-integration? |
| D. | Are few or many sources of the early intermediates available? |
| E. | Can the API supplier produce the early intermediates economically compared to sourcing them? |
| F. | Is the supplier sourcing an advanced intermediate from a third party? |
| G. | Does the supplier have a formal contractual commitment from the advanced intermediate supplier? |
| H. | Is the intermediate supplier also producing and selling the API? |
| I. | What is the capacity of the intermediate manufacturer compared to the expected demand? |
| J. | What is the lead time for new deliveries of the intermediate? |
| K. | What are the API manufacturer's plans for holding inventory of the key intermediate? |
| 2. | Manufacturing capacity |
| A. | Will the API be manufactured in a dedicated or multi-purpose facility? |
| B. | What is the installed capacity today? |
| C. | What is the capacity expansion plan to support demand when the generic product launches? |
| D. | What contingency plans are in place to cover the upside potential? |
| E. | If the facility is multi-purpose, what other products are manufactured and what is the potential capacity utilization by these products in the timeframe when the generic firm expects to launch? |
| 3. | Production planning and inventory management |
| A. | Will the supplier produce the API continuously or in campaigns? If in campaigns, how many per year and to what scale? |
| B. | Will the supplier hold inventory of starting materials, advanced intermediates or API? |
| C. | Does the supplier have a warehouse in close proximity to the generic firm’s plant? If the supplier can warehouse the API after clearing customs in the same country as the generic firm’s plant, the lead-time for new deliveries can be dramatically reduced. |
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Launch Management
In some cases, the exact launch date for a new generic product is not known until days or weeks before the launch itself. Clearly it is not possible to prepare adequately for a successful on-time launch if the strategy is to start preparation only when the launch date is fixed. Therefore, a risk-based approach is required. Since the purchasing of API is often the largest single investment in launch preparation and requires the longest lead-time, a risk-based approach requires cooperation between the generic firm and the API manufacturer. The options for optimizing the sharing of risks and benefits of launch preparation are limited only by the creativity of the generic and API manufacturing firms. The following are brief outlines of some risk-sharing strategies:
1. Joint funding of the production of API required to launch. The generic firm and API manufacturer share the investment in the cost to manufacture the inventory required for launch. The generic firm agrees on a net API price is to be paid upon delivery of the material when the launch date is known. In this way, the generic firm is not exposed to the full expense of purchasing the API at the full “market price” with the risk of not being able to take delivery of the API nor sell product, if the launch is delayed. Likewise the API manufacturer is not exposed to the full risk of investing in production of the API in anticipation of the generic firm’s order.
2. Scenario-based pricing. It is possible to share risks and benefits by reaching agreement on multiple levels of API pricing based upon various market scenarios that could arise. The API is transferred to the generic firm at a price equivalent to the most likely scenario or the lowest price scenario. The final price is adjusted after launch to the net price agreed for the actual market scenario at launch.
3. Consignment inventory. If the API manufacturer regularly produces the API for other end uses, an effective solution to launch management risk sharing is for the API manufacturer to manage an inventory of API at the generic firm’s warehouse or at a warehouse managed by the API manufacturer in close proximity to the generic firm’s plant. The API manufacturer can rotate the inventory within an agreed timeframe from the original manufacturing date. When the generic firm is ready to start launch preparation, the inventory will be ready for processing immediately.
Cost Competitiveness
Due to the commodity nature of the generic pharmaceutical market, cost competitiveness of the generic firm is a critical success factor. The API cost is typically the single greatest component of COGS. When selecting an API manufacturer that can deliver all of the API objectives needed for obtaining a prompt new product approval and delivering excellent customer service after approval, the sourcing manager must also ensure that the API cost will be more competitive than the costs incurred by his competitors. There is increasing activity by generic firms to vertically integrate into production of API, creating an added dynamic to this element of the sourcing manager’s strategy development. However, this will not be discussed in detail here.
It is essential to understand the cost drivers for API production. This requires an understanding of the chemical technology used and the cost components of that technology. In some cases, the leading cost driver will be the starting materials. In others, it will be the plant overhead for highly specialized unit operations. The sourcing manager must develop a relationship with his API manufacturer where there is sufficient mutual trust to jointly analyze the cost drivers and develop cost improvement plans where the benefits can be shared by both parties.
Other critical factors impacting the cost competitiveness of the API manufacturer are:
1. The manufacturing system used: Typically a dedicated prodtion facility will result in lower costs per unit. This is particularly true if the dedicated equipment and the process are highly automated and the manufacturer has sufficient volume to deliver real economies of scale. It is less commonly used by API manufacturers because of the uncertainty of the volume demand and the high cost of investment in capacity that cannot easily be adjusted to accommodate production of other products if the volume for the product for which it was designed does not materialize.
2. Multi-purpose production equipment is the more common strategy adopted by generic API manufacturing companies. It has the advantage of creating a high level of flexibility to produce multiple products on a campaign basis in the same production unit. Upswings in demand for one API can be absorbed by lower demand for another, and a relatively flat capacity utilization and overhead absorption can be maintained. This flexibility comes at the cost of increased overhead per unit due to the need for inter-campaign equipment cleaning and down-time. Campaign production results in fluctuating lead-times for filling API orders and results in peaks and valleys in inventory levels. A sophisticated production scheduling system is required with close integration to the MRP system of the generic firm. It is less suitable for production requiring highly specialized technology or equipment, because it will require installation of large-capacity units of the specialized equipment in order to accommodate the annual demand, but be used only on intermittent campaigns. This specialized equipment will lie idle while other products are manufactured in the plant's general purpose equipment.
Maintaining Cost Competitiveness
Similar to optimizing the launch preparation process, a risk management approach to maintaining cost competitiveness and profitability can yield benefits for both the generic firm and API manufacturer. The traditional model of API transactions is that the generic firm places individual purchase orders for requirements needed for a period of time, usually less than one year. Typically no formal contract exists other than the purchase order terms. This model creates limitations for both parties. The primary limitation for the API manufacturer is that the company is never clear on the extent of the generic firm's commitment to continue purchasing from them for the long term. The sourcing manager and API marketing manager may have an excellent relationship and understanding but the other levels of management within the API firm may not have a high comfort level in the commitment and sustainability of the relationship. This manifests itself in an arms-length approach to negotiations. The major negative for the generic firm is that it is involved in a continuous process of negotiation and renegotiation that may not deliver continuously competitive costs.
Most significantly, due to the lengthy cycle time from order of API to shipping of finished goods, when a new price is agreed upon it will be many months before the reduction in COGS hits the P&L. The work-in-progress is valued using the old API cost and must move through the supply chain before the benefit of lower API cost is captured.
A significant disconnect exists in the market dynamics between the generic firm and its customers and the market dynamics between the generic firm and its API manufacturers. The standard practice by the generic firm’s customers in most markets is to include inventory price protection in the supply contract. This is uncommon in the terms of agreement between generic firms and API manufacturers. However, the pressure to fix this imbalance is intense and the successful generic firms will find strategies to address it to the mutual benefit of the business for both themselves and their API manufacturers. One approach to solving this imbalance is very common in agreements covering the supply of finished products to the generic firm. In these cases the payments to the manufacturer are structured as a percentage of either the generic firm’s net sales or gross margin based on an agreed transfer price for the products. This structure has the benefit of calculation the net cost to the generic firm after the sale has been made to the customer. The critical elements of these agreements are the transfer price and floor price. This model requires absolute transparency regarding components of the transfer price.
Multi-source Qualification Strategy
The generic pharmaceutical market is by definition a commodity market. The generic firm’s customers, pharmacy chains, wholesalers, hospitals, etc. experience minimal barriers to changing suppliers of drug products and can negotiate from a position of significant strength. Contrary to the limited barriers to changing suppliers experienced by the generic firm’s customers, significant barriers exist to change any element of the generic firm’s supply chain. As mentioned previously, the API is the single greatest contributor to COGS. Therefore, as the generic firm experiences margin pressure, negotiation of the cost of API is critical to maintaining competitive costs. The negotiation process and the potential outcomes are influenced by many factors that have been the subject of extensive studies and will not be discussed here. However, the most significant dynamic in the negotiation process is that the generic firm has usually only two source options or in some cases a single option for supply of API. This contrasts dramatically with the almost purely commodity nature of the negotiations that the generic firm’s sales and marketing team face when selling their products.
One strategy adopted to address this imbalance is to qualify multiple API sources. This increases the leverage of the sourcing manager in the negotiations. It also creates flexibility in the supply chain to absorb the volatility in demand and potential interruptions in supply. The sourcing manager must establish a clear process for identifying the projects for which qualifying a single source presents a low risk and the projects for which multiple sources must be qualified. To be effective the sourcing manager must secure buy-in from senior management and the heads of functions involved in qualification of the additional sources. A subtle balance must be created between the single-source risk and the cost to complete the qualification of the multiple sources. This additional cost includes not only the costs associated directly with the qualification but also the opportunity cost associated with the new products that could be developed by the scientific staff who work on the additional source qualifications.
In summary, the API sourcing function plays a key role in driving the success of the generic firm. To be successful, the sourcing team must possess and apply a broad working knowledge of all functions within the generic business. It must lead cross-functional development and implementation of sourcing strategies from product selection, development, launch, manufacturing and sales. It must create added value opportunities by providing expert input to the strategic planning processes. The successful generic firm positions API sourcing within the organization at a strategic level where it can capture value creation opportunities using its in-house sourcing expertise and network of external API manufacturer relationships.
The views of Mr. Stafford do not necessarily reflect the views or policies of Sandoz GmbH.
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