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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 20 days

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.

Manufacturer usually replies in 7 days

linaclotide

Capsules 145 mcg, 290 mcg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
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.

Manufacturer usually replies in 29 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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