The company sources raw materials for BIO101 (20-hydroxyecdysone) and BIO201 from third-party suppliers. The active pharmaceutical ingredient (API) for BIO101 is purified from Cyanotis sp or Stemmacantha sp plants cultivated in China. Currently, the company relies on a single supplier for the starting material without a long-term supply agreement, but with an arrangement sufficient for ongoing clinical programs. Purification of BIO101 is performed by Seqens, a manufacturing partner in France, under GMP compliance, with the partnership established in July 2023. Manufacturing activities are based on processes developed with the former partner Patheon/Thermofisher. Additionally, the company initiated a partnership with Skypharma in France in September 2023 to produce BIO101 in its final capsule form. The company plans to scale up sourcing and manufacturing depending on regulatory outcomes and is exploring alternative production methods and plant sources. The API for BIO201, norbixin, is produced by chemical conversion from bixin for preclinical development.
Biophytis Sa's Comment on Supply Chain
The company sources raw materials for BIO101 (20-hydroxyecdysone) and BIO201 from third-party suppliers. The active pharmaceutical ingredient (API) for BIO101 is purified from Cyanotis sp or Stemmacantha sp plants cultivated in China. Currently, the company relies on a single supplier for the starting material without a long-term supply agreement, but with an arrangement sufficient for ongoing clinical programs. Purification of BIO101 is performed by Seqens, a manufacturing partner in France, under GMP compliance, with the partnership established in July 2023. Manufacturing activities are based on processes developed with the former partner Patheon/Thermofisher. Additionally, the company initiated a partnership with Skypharma in France in September 2023 to produce BIO101 in its final capsule form. The company plans to scale up sourcing and manufacturing depending on regulatory outcomes and is exploring alternative production methods and plant sources. The API for BIO201, norbixin, is produced by chemical conversion from bixin for preclinical development.
Sources:
Biophytis Sa'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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