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Country of origin : China

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linaclotide

Injection 290 μg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
China
Manufacturer #29288
This hi-tech enterprise specializes in the research and manufacturing of diverse peptide products. Founded in 1998, it has become one of the leading peptide pharmaceutical companies globally, offering a full range of services including finished dosage products, APIs, and CRO/CMO services. Their finished dosage products are primarily sold domestically, while APIs have international distribution. The company operates a GMP-certified manufacturing facility exceeding 1500 sq. m., regularly inspected by local and international authorities. They focus on several key therapy areas, employing various principal dosage forms, including peptide-based formulations.

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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.

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