linaclotide Capsules 145 mcg, 290 mcg
Dossier type
CTD
Dossier status
Under development
Country of origin
China
GMP approvals
China
Manufacturer #38358
Manufacturer established in 2019 in Hangzhou, China; fewer than 100 employees formally listed. As a CTD dossier owner and manufacturer, it maintains a quality-assurance system aligned with China GMP, EU cGMP, US FDA standards. Acts as a GMP manufacturer, running 7 peptide API production lines in its GMP factory in Zhejiang, with annual capacity of ~1,000 kg peptide APIs. Products have been registered and sold in China, USA, Europe, Japan, and other regions. As a CTD dossier owner and manufacturer, it handles peptide R&D, impurity profiles, and regulatory filings. Recognized also as a GMP manufacturer for export-grade production.
Linaclotide is a medication used to treat constipation and irritable bowel syndrome. Suppliers of linaclotide market it in the form of 0.072mg, 0.145mg and 0.29mg oral tablets.
The developer and earliest manufacturer of linaclotide is Ironwood Pharmaceuticals, who first acquired marketing authorization for the drug in 2012. Currently, the two largest producers and suppliers of linaclotide are Allergan and Astellas, the latter of which markets the drug across Asian markets while Allergan covers all the other geographic markets where linaclotide is approved (e.g. the U.S. and Europe). With the patent for the drug still valid, generic versions of linaclotide have yet to become available on the pharmaceutical market from other manufacturing companies.
One of the main alternatives to linaclotide is plecanatide, which is marketed under the trade name Trulance by manufacturer Synergy Pharmaceuticals.