The company outsources drug substance and drug product manufacturing to qualified third-party suppliers and does not maintain its own manufacturing facilities. It has agreements with third-party manufacturers for the production of bulk drug substances, as well as for formulation, packaging, and distribution of its product candidates. Currently, all drug substances are manufactured by single suppliers, with formulation and distribution also handled by single suppliers. The company recognizes the limited number of manufacturers and the challenges associated with transferring technology to alternative suppliers. Existing supply agreements cover development stages only, and secondary suppliers will be qualified upon obtaining marketing approval. Additionally, the company has an agreement with SciClone, which granted access to SciClone's oral mucositis clinical and regulatory data library in exchange for exclusive commercialization rights for SGX942 in China, including Hong Kong.
Soligenix Inc's Comment on Supply Chain
The company outsources drug substance and drug product manufacturing to qualified third-party suppliers and does not maintain its own manufacturing facilities. It has agreements with third-party manufacturers for the production of bulk drug substances, as well as for formulation, packaging, and distribution of its product candidates. Currently, all drug substances are manufactured by single suppliers, with formulation and distribution also handled by single suppliers. The company recognizes the limited number of manufacturers and the challenges associated with transferring technology to alternative suppliers. Existing supply agreements cover development stages only, and secondary suppliers will be qualified upon obtaining marketing approval. Additionally, the company has an agreement with SciClone, which granted access to SciClone's oral mucositis clinical and regulatory data library in exchange for exclusive commercialization rights for SGX942 in China, including Hong Kong.
Sources:
Soligenix 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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