Ironwood Pharmaceuticals Inc's Comment on Supply Chain
The commercial suppliers of linaclotide API are responsible for producing the active pharmaceutical ingredient in compliance with Good Manufacturing Practices (GMP) and are subject to inspections and audits. AbbVie, Astellas, and AstraZeneca each manage linaclotide API, finished drug product, packaging, and distribution within their respective territories. For apraglutide, the company does not own manufacturing facilities but collaborates with contract development and manufacturing organizations (CDMOs) to produce clinical and potential commercial quantities. The company employs personnel experienced in managing these CDMOs. Apraglutide is currently supplied as a lyophilized powder for injection, with ongoing development of new drug presentations to improve patient convenience. Suppliers named across filings include AbbVie, AKP, Astellas, and AstraZeneca.
Ironwood Pharmaceuticals Inc's Comment on Supply Chain
The commercial suppliers of linaclotide API are responsible for producing the active pharmaceutical ingredient in compliance with Good Manufacturing Practices (GMP) and are subject to inspections and audits. AbbVie, Astellas, and AstraZeneca each manage linaclotide API, finished drug product, packaging, and distribution within their respective territories. For apraglutide, the company does not own manufacturing facilities but collaborates with contract development and manufacturing organizations (CDMOs) to produce clinical and potential commercial quantities. The company employs personnel experienced in managing these CDMOs. Apraglutide is currently supplied as a lyophilized powder for injection, with ongoing development of new drug presentations to improve patient convenience. Suppliers named across filings include AbbVie, AKP, Astellas, and AstraZeneca.
Sources:
Ironwood 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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