How to choose an API?
Selecting an API supplier is one of the most important decisions a pharmaceutical manufacturer will make. How do you select the one that is right for you? Our customers have provided valuable feedback on qualities of API suppliers that can help meet their expectations. We’ve combined customer recommendations, along with our experiences, to offer these seven key factors for consideration.
1. Demonstrates longevity and a proven track record.
With so many new products going off-patent in 2028 and beyond, customers expressed that it is important to secure an established supplier who is likely to be around when your product is ready to launch and stays on top of changing compliance regulations. In this fast-paced competitive industry, a smaller supplier may be acquired or change its capabilities, which could disrupt your go-to-market plans.
2. Maintains high standards for quality processes.
Another critical factor our customers identified is learning about proactive efforts the supplier has in place to protect their systems from data manipulation. During inspections, the FDA and other regulatory agencies check data integrity and issue warning letters when they find problems, which becomes a significant red flag. Officials are also looking for violations of environmental regulations. For example, Chinese authorities are clamping down on pollution, which is affecting manufacturers across select regions. Our customers have suggested checking whether prospective suppliers have a plan in place to address these new risks.
3. Has an agile R&D team able to develop the right products at the right time.
Global markets will continue to demand increased flexibility to develop products that weren’t in the original pipeline. Customers feel it is important for their supplier’s R&D team to have the flexibility to re-prioritize their facilities to develop products for them that are relevant in the moment.
4. Adapts to changing regulatory requirements.
Many APIs were developed years ago when regulatory requirements were different. Reliable suppliers were described by our customers as those who revamp their processes to ensure older APIs meet the current standards and reflect up-to-date requirements for the customer’s target markets. They also expressed that documentation readiness would be a priority to help the submission process go smoothly, ensuring that DMFs and other documents are well-organized, complete, readily available, and that the information is filed on time with the appropriate agency. At Teva api, customers can easily and quickly access and download more than 5,000 API and manufacturing site regulatory documents on Teva api Online – our online customer platform.
5. Addresses regulators’ questions and deficiencies in a timely manner.
With companies being granted approvals for ANDAs quicker than ever, experience has taught us that API suppliers need knowledgeable Regulatory Affairs teams at the global and local levels who can work with the FDA and other regulatory agencies to respond to questions promptly. Customers expressed concern that less mature suppliers may not have the experience or a process in place to resolve regulatory issues quickly, which could delay a manufacturer’s product launch.
6. Prepares for launch readiness years in advance.
Customers also appreciate when suppliers are able to support their launch plans by preparing in advance. They also have advised that as each launch date approaches, it is important to have a protocol in place whereby the supplier and customer meet regularly to be certain both are in sync with production timelines.
7. Understands the market landscape.
While customers consider price an important factor, they deem other criteria to be equally significant in the selection process. In our experience, suppliers with a solid understanding of the market know that many criteria are taken into account when setting a reasonable API price, including raw materials, development costs, insurance, shipping, taxes, level of customer service and dedicated functions to accompany the customer throughout the project lifecycle, and other fees. Given the realities of the many elements that go into a market strategy, customers advised that unexpected low prices may often result in additional costs or shortfalls elsewhere down the line. As such, manufacturers are often wary of any supplier who offers a drastically below-market price. It is also important to check that the supplier doesn’t have a warning letter that might affect their ability to support the project.
APIs are the fundamental building blocks of today’s drug products, and selecting an API supplier demands careful consideration. Our customers have asked us to provide as much information as possible to support their important strategic decisions to help them stay competitive. We have made it a practice to share our knowledge, capabilities, and best practices to support customer requirements and requests.
The seven factors outlined above, based on ongoing input from our customers and our experience, are things you may want to consider to help you make an informed decision. Your Active Pharmaceutical Ingredients supplier is a long-term partner who will support your needs – and your success – for many years to come.
Based on Customer Feedback, Questions to Ask When Selected an API Supplier
- Does the supplier have a proven track record in the markets where you will be doing business?
- Has the supplier revamped their processes to ensure older APIs meet the current standards?
- Are DMFs and other documents well organized, complete, and easily accessible for customers?
- Does the supplier’s R&D team have industry experience and the flexibility to support your specialized needs?