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biapenem

Injection, lyophilized 0.3 g

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
China
Manufacturer #31064

Established in 1970, this Chinese manufacturer specializes in the research, development, production, and sales of a wide range of pharmaceutical products. As a CTD dossier owner and manufacturer, it ensures compliance with international quality standards. The company operates advanced production lines across four industrial parks, covering approximately 1,333,400 square meters, and employs nearly 5,000 individuals, including over 2,000 professional and technical personnel. Its diverse product portfolio includes anesthetic agents, psychotropic medicines, nonsteroidal anti-inflammatory drugs, cardiovascular system medicines, antibiotics, and antiviral medicines. As a CTD dossier owner and manufacturer, its products are distributed across multiple countries worldwide. The manufacturer holds GMP certifications from international regulatory authorities, including the U.S. FDA and the Philippines FDA, ensuring adherence to stringent global quality standards

Manufacturer usually replies in 5 days

biapenem

Injection 0.3 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 20 days

biapenem

Vials, injection 0.3 g, 0.6 g

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
WHO
Manufacturer #9406
A pharmaceutical manufacturer capable of both active pharmaceutical ingredients (APIs) and finished dosage forms, offering a wide portfolio of pharmaceutical products including oncology-oriented APIs and orphan-disease formulations. The company’s production facilities hold recognised quality certifications such as WHO-GMP, EU-GMP

Manufacturer usually replies in 24 days

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