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Linaclotide manufacturers

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Country of origin : Bangladesh

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2 products found

linaclotide

Capsules 72 mcg, 290 mcg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Bangladesh
GMP approvals
Bangladesh
Manufacturer #36531

Established in 1963, this manufacturer specializes in producing hormones, steroids, and other pharmaceutical products in various dosage forms, including tablets, capsules, injections, and ophthalmic drops. As a CTD dossier owner and manufacturer, it holds GMP approvals from multiple international regulatory authorities, including the U.S. FDA, the Therapeutic Goods Administration (TGA) of Australia, and the Malta Medicines Authority (European Union). The manufacturer operates advanced production lines adhering to stringent GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed in multiple countries worldwide.

 

 

 

 

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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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