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dexlansoprazole

Capsules, modified release (MR) 30 mg, 60 mg

Dossier type
US CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
FDA, EU GMP
Comments
Ref. Dexilant
Manufacturer #31058

This company, based in Europe, is a pharmaceutical manufacturer with a history spanning over seven decades. They focus on the development, production, and marketing of generic and value-added medicines, catering to patients globally. Their expertise lies in complex generics and their portfolio includes prescription drugs and over-the-counter medications. They hold significant experience in the industry, with strong manufacturing capabilities in Europe and North America, backed by GMP certifications. The company has a robust track record of growth, demonstrated by its international presence and expansion into key regions such as Europe and North America. Key therapy areas include cardiovascular, oncology, and gastrointestinal disorders. Their production lines include solid dosage forms, injectables, and liquids.

Manufacturer usually replies in 14 days

dexlansoprazole

Capsules, delayed release (DR) 30 mg, 60 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
WHO
Manufacturer #17643
This company specializes in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and intermediates, focusing on cost-effective solutions with a strong emphasis on quality. They offer contract development and manufacturing services (CDMO) for both New Chemical Entities (NCEs) and APIs, leveraging their globally compliant GMP facilities and expertise in modified release technologies. The company boasts state-of-the-art production lines capable of handling high-potent materials across various scales, catering to a wide range of pharmaceutical products including prescription medications and potentially over-the-counter drugs. While specific therapy areas aren't mentioned, they hold patents for their innovations and are actively involved in research and development. Their operations span multiple regions, including North America and the EU.

Manufacturer usually replies in 2 days

dexlansoprazole

Capsules, delayed release (DR) 30 mg, 60 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
India
Manufacturer #16857
A pharmaceutical manufacturer with integrated capabilities in active pharmaceutical ingredients, intermediates, and finished formulations, supplying pharmaceutical products to global partners across key therapy areas such as diabetes, cardiac care, neurology, anti-bacterial and anti-fungal segments. The organisation highlights strong in-house R&D, backward integration into intermediates and APIs, and scalable manufacturing from development to multi-ton commercial output. For quality, the site states that its formulation manufacturing operates in a GMP-compliant facility recognised by major regulators, and specifically lists approvals/recognition including USFDA, EU-GMP, WHO and TGA, supporting reliable international supply of pharmaceutical products.

Manufacturer usually replies in 10 days

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