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Generics 8

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Selexipag manufacturers

8 products found

Filters

8 products found

selexipag

Tablets 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Dossier availability date: Q2 2025 Western EU SPC Expiry: 25 Apr 2027
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 6 days

selexipag

Tablets, film coated 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1000 mcg, 1200 mcg, 1400 mcg, 1600 mcg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP, FDA
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 24 days

selexipag

Tablets 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1000 mcg, 1200 mcg, 1400 mcg, 1600 mcg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
United States
GMP approvals
FDA
Manufacturer #28190
This privately held company develops, manufactures, and commercializes high-quality, affordable generic pharmaceuticals globally. Their focus is on products with formulation challenges and first-to-market opportunities within the generic space. Key therapeutic areas include those requiring complex formulations like injectables, sterile ophthalmic, and dermal products. They specialize in solid oral dosage forms through partnerships with other manufacturing facilities. The company holds GMP certifications and has a track record of developing patented product formulations. Their main production facility in North America is equipped for multi-format packaging and end-product release testing, ensuring a seamless process from bulk manufacturing to finished goods.

Manufacturer usually replies in 7 days

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