The company adheres to FDA and DEA regulations in its manufacturing processes, sourcing raw materials such as active pharmaceutical ingredients (APIs) and components from both domestic and international suppliers. Typically, the company qualifies a single source of API per product due to the cost and time involved in validation, requiring FDA approval through a prior approval supplement (PAS) for any changes, a process that can take six to nine months or longer. Non-API raw materials generally have a single source with a less rigorous qualification process. Supplier changes are infrequent and based on quality, reliability, and financial stability. Some APIs, including those for products without approved NDAs or ANDAs, are sourced internationally and may experience supply disruptions due to FDA inspections and customs delays. Several key products, including injectables, softgel capsules, Cortrophin Gel, and ILUVIEN, are manufactured and supplied by third parties. The company does not have in-house manufacturing for Cortrophin Gel or ILUVIEN, making it dependent on these third-party manufacturers.
Ani Pharmaceuticals Inc's Comment on Supply Chain
The company adheres to FDA and DEA regulations in its manufacturing processes, sourcing raw materials such as active pharmaceutical ingredients (APIs) and components from both domestic and international suppliers. Typically, the company qualifies a single source of API per product due to the cost and time involved in validation, requiring FDA approval through a prior approval supplement (PAS) for any changes, a process that can take six to nine months or longer. Non-API raw materials generally have a single source with a less rigorous qualification process. Supplier changes are infrequent and based on quality, reliability, and financial stability. Some APIs, including those for products without approved NDAs or ANDAs, are sourced internationally and may experience supply disruptions due to FDA inspections and customs delays. Several key products, including injectables, softgel capsules, Cortrophin Gel, and ILUVIEN, are manufactured and supplied by third parties. The company does not have in-house manufacturing for Cortrophin Gel or ILUVIEN, making it dependent on these third-party manufacturers.
Sources:
Ani Pharmaceuticals Inc's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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