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Country of origin : India

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nirmatrelvir + ritonavir

Tablets 150 mg + 100 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #34252

Established in 2004, this vertically integrated pharmaceutical manufacturer is committed to delivering high-quality, affordable medicines globally. As a CTD dossier owner and manufacturer, it holds GMP certifications from the US FDA, EU, and WHO, ensuring compliance with stringent international quality standards. The company's state-of-the-art R&D center is capable of handling oral solids, liquids, and parenteral formulations. Its products have received marketing authorizations from regulatory authorities such as the US FDA, Health Canada, CDSCO-India, and New Zealand. With over 20 ANDA/ANDs under approval, the manufacturer operates advanced production lines adhering to rigorous GMP guidelines. Its diverse portfolio includes therapeutics in areas like antivirals, neurology, women's health, cardiology, and imaging contrast agents.

Manufacturer usually replies in 8 days

atazanavir + ritonavir

Capsules 300 mg + 100 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #38728

Established in 2012, this Manufacturer is a CTD dossier owner and manufacturer and GMP manufacturer with products sold in over 39 countries across four continents. With multiple WHO-GMP and other regulatory approvals (e.g., Ghana FDA, Philippines FDA, Kenya PBB, Tanzania TFDA, Nigeria NAFDAC), it operates several finished dosage and R&D production lines (tablets, capsules, injectables, liquids, softgels, effervescent, suppositories). As a CTD dossier owner and manufacturer, it supports regulatory filings worldwide. Headquartered in India and employing a global workforce, it serves diverse markets as a CTD dossier owner and manufacturer and GMP manufacturer.

Manufacturer usually replies in 16 days

ritonavir

Capsules 100 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #19820
A pharmaceutical manufacturer supplying a broad range of pharmaceutical products, including tablets, capsules, syrups, ointments and other dosage forms, and offering both branded medicines and contract-manufacturing services. The company operates GMP-certified facilities (including WHO-GMP and EAEU-GMP) and maintains integrated quality-control, R&D and logistical systems to ensure consistent safety, efficacy and compliance of its pharmaceutical products.

Manufacturer usually replies in 58 days

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