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Country of origin : India
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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 30 mg, 60 mg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
FDA
Manufacturer #1808
A pharmaceutical manufacturer offering a comprehensive range of pharmaceutical products, including oral solids (tablets and capsules), oral liquids, injectables, ophthalmic suspensions & solutions, inhalation and topical formulations. The company leverages advanced drug-delivery technologies such as nano-encapsulation and specialty pellet systems, provides contract research and manufacturing services, and holds international quality approvals including EU-GMP and WHO-GMP for its facilities.

Manufacturer usually replies in 57 days

dexlansoprazole

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

Dossier type
US CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA
Comments
Reference product: Dexilant®
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 27 days

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