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Country of origin : India

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cefpirome

Solution for injection 1000 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #33692

Established in 1991, this Indian manufacturer specializes in dry powder Penicillin and Cephalosporin injectables. As a CTD dossier owner and manufacturer, it holds EU GMP and PIC/S certifications, ensuring compliance with international quality standards. The facility, located in Vapi, Gujarat, operates advanced production lines with a capacity of 10 million vials per month on a single shift, adhering to stringent GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed both domestically and internationally

Manufacturer usually replies in 15 days

cefpirome

Injection 1000 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #36197

Established in 2018, this manufacturer specializes in exporting and manufacturing pharmaceutical active pharmaceutical ingredients (APIs) and finished formulations, including tablets, capsules, pre-filled syringes, dry syrups, creams, ointments, injectables (liquids and powder), eye/ear drops, IV fluids, and surgical products. As a CTD dossier owner and manufacturer, it holds EU/WHO GMP certifications, ensuring compliance with international quality standards. The manufacturer operates advanced production lines adhering to stringent GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed across various regions, including Central America, non-EU Europe, the Middle East, Oceania, South America, and South Asia.

Manufacturer usually replies in 77 days

cefpirome + sulbactam

Injection 750 mg, 1.5 g, 3 g

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #2303
A pharmaceutical manufacturer with over 25 years of experience that develops and produces fixed-dose and single-entity generic and specialty pharmaceutical products. The company offers an extensive range of injectable dosage forms, including parenterals, and also manufactures oral solids. Its facilities operate under recognised international quality certifications such as EU-GMP, ANVISA, PIC/S and TGA approvals, supporting reliable large-scale production of pharmaceutical products for global export while emphasizing efficacy, affordability and consistent quality.

Manufacturer usually replies in 21 days

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