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tenofovir alafenamide + emtricitabine + rilpivirine

Tablets, film coated 25 mg + 200 mg + 25 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Comments
Ref. product: Odefsey® Gilead Sciences
Manufacturer #261
A pharmaceutical manufacturer based in the EU that has been selling its products in Europe for 20+ years. Main therapeutic areas include diabetes, CNL, dermatology, and oncology. Main dosage forms include solid and liquid oral, sterile dosage forms, and ointments. The company possesses 10+ manufacturing facilities that are cGMP-compliant.

Manufacturer usually replies in 20 days

emtricitabine + rilpivirine + tenofovir alafenamide

Tablets, film coated 200 mg + 25 mg + 25 mg, 200 mg + 27.5 mg + 28 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #4185
Pan-European generics company with decades of experience providing affordable Rx and OTC medicines across 40+ European countries. Portfolio spans oral solids, liquids, and semi-solids covering cardiovascular, CNS, pain, and metabolic therapy areas. Manufacturing lines hold EU-GMP approvals across multiple European production sites.

Manufacturer usually replies in 13 days

rilpivirine

Tablets, film coated 25 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Ref: Edurant ®
Manufacturer #337
A pharmaceutical manufacturer based in the EU that has been active in 90+ countries selling its products in the EU, Africa, North America, Middle East, and Asia for 30+ years. Key production lines are Rx and OTC. Main therapeutic areas include diabetes, CNS, and dermatology. The company's production lines are GMP-compliant. The company possesses branches in the Middle East and Asia.

Manufacturer usually replies in 17 days

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