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linaclotide

Capsules 72 mcg, 145 mcg, 290 mcg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #17457
In the past fifty years, the company has reached significant milestones—a result of enviable performance, strict adherence to the highest ethical and operational standards, and full compliance with global regulatory authorities. During this journey, they have emerged as one of the leading in-house development partners based in Europe, specializing in the development, registration, manufacturing, and life-cycle management of highly complex pharmaceutical technologies and generic formulations.

Manufacturer usually replies in 40 days

linaclotide

Capsules 72 mg, 145 mg, 290 mcg

Dossier type
US CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
FDA, EU GMP
Manufacturer #276
This company is a global manufacturer and distributor of high-quality generic medicines, with a mission to make these medicines accessible to patients worldwide. It operates in several regions, including Europe and Latin America, and emphasizes strong partnerships within the pharmaceutical industry to expand its reach. The company is committed to sustainability and transparency, following Environmental, Social, and Governance (ESG) principles. They regularly engage in major industry events, highlighting their dedication to networking and maintaining a leading position in the market for generic medications.

Manufacturer usually replies in 18 days

linaclotide

Capsules 72 mcg, 145 mcg, 290 mcg

Dossier type
US CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
FDA, EU GMP
Manufacturer #17457
In the past fifty years, the company has reached significant milestones—a result of enviable performance, strict adherence to the highest ethical and operational standards, and full compliance with global regulatory authorities. During this journey, they have emerged as one of the leading in-house development partners based in Europe, specializing in the development, registration, manufacturing, and life-cycle management of highly complex pharmaceutical technologies and generic formulations.

Manufacturer usually replies in 40 days

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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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