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Linaclotide manufacturers

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Country of origin : India
3 products found

linaclotide

Capsules 72 mcg, 145 mcg, 290 mcg, 75 mcg

Dossier type
US CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA
Comments
Reference product: Linzess®
Manufacturer #15189
The company, which was founded in 1989, is involved in developing, manufacturing, and distributing a wide range of formulations for anti-infectives, cardiovascular, anti-diabetic, dermatological, and hormone treatment. The corporation has a global presence in 170 + countries, 60+ WHO-prequalified medications, and 3700+ product registrations.

linaclotide

Capsules 72 mcg, 145 mcg, 290 mcg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP, ANVISA, TGA, Mexico, South Africa
Manufacturer #9258

This company is a research-driven pharmaceutical manufacturer specializing in oral solid dosage forms. They offer both pharmaceutical and nutraceutical products, including pre-formulation intermediates like granules and pellets, as well as finished formulations such as tablets, capsules, and oral thin films. Their focus is on developing differentiated generic products using innovative process technologies to enhance patient convenience and affordability. Key therapy areas include urology, cardiovascular health, infectious diseases, gastrointestinal disorders, pain management, vitamins, and skin conditions. The company holds EU-GMP certifications alongside WHO-GMP, ISO 9001, and NSF/ANSI 455-2 certifications. They operate with a robust R&D center recognized by the Indian government and collaborate with pharmaceutical companies globally for product development and marketing.

linaclotide

Capsules 72 mcg, 145 mcg, 290 mcg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Comments
Reference: Constella; Linzess
Manufacturer #22642

Established in 1997, this manufacturer excels as a CTD dossier owner and manufacturer, known for its extensive reach in over 65 countries. It upholds high standards as a GMP manufacturer with advanced production lines and significant expertise in pharmaceuticals, making it a top-tier GMP manufacturer and CTD dossier owner and manufacturer. This commitment ensures compliance with rigorous international standards, maintaining its status as a leading CTD dossier owner and manufacturer.

 

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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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