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Betamethasone acetate manufacturers

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Country of origin : India

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1 products found

betamethasone acetate + betamethasone sodium phosphate

Vials, injection 3 mg/ml + 3 mg/ml - 5 ml

Dossier type
US CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA
Comments
ANDA / R &D Status: ANDA to be filed in Q4-2023, approval expected Q4-2024; US RLD / Holder: Celestone Soluspan / Organon LLC ; Indication: corticosteroid antiallergic;
Manufacturer #8216
This fast-growing pharmaceutical company boasts a dominant presence in Latin America, Francophone Africa, and a growing footprint in regulated markets like the EU and North America. Founded in 1990, it initially focused on ointments and creams before expanding its product range significantly. With over 4,000 global product licenses, they cater primarily to the "Bottom of the Pyramid" through their owned distribution networks. The company's manufacturing facility holds multiple certifications including US FDA approval (with three successful inspections since 2016), EU-GMP, ANVISA-Brazil, INVIMA-Colombia, and COFEPRIS-Mexico. They prioritize innovation with a significant portion of their earnings invested in research and development of safe and effective products across various dosage forms. Key therapy areas are not specified.

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