The company depends on third-party contract manufacturing organizations (CMOs) and suppliers, including Mayne Pharma, for raw materials and active pharmaceutical ingredients (API) used in products such as ANNOVERA and BIJUVA. Mayne Pharma is involved in manufacturing specification requests. Risks exist if suppliers or CMOs fail to meet agreement terms, allocate adequate resources, or if the FDA does not approve manufacturing changes. Such issues could lead to supply interruptions, affecting revenue and commercialization. Additionally, licensees may not have long-term contracts for API supply, increasing the risk of supply disruptions.
Therapeuticsmd Inc's Comment on Supply Chain
The company depends on third-party contract manufacturing organizations (CMOs) and suppliers, including Mayne Pharma, for raw materials and active pharmaceutical ingredients (API) used in products such as ANNOVERA and BIJUVA. Mayne Pharma is involved in manufacturing specification requests. Risks exist if suppliers or CMOs fail to meet agreement terms, allocate adequate resources, or if the FDA does not approve manufacturing changes. Such issues could lead to supply interruptions, affecting revenue and commercialization. Additionally, licensees may not have long-term contracts for API supply, increasing the risk of supply disruptions.
Sources:
Therapeuticsmd 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.
Updated on:
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