phytonadione Injection 1 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Indonesia
GMP approvals
Indonesia
Manufacturer #20699

This Southeast Asian CTD dossier owner and manufacturer specializes in reproductive healthcare, offering a range of prescription and non-prescription products. They are recognized for their commitment to affordable contraceptives and operate with international quality standards. Their product portfolio includes hormone and non-hormone options, as well as herbal products and medical devices. The company has a strong track record in the region, having earned Good Manufacturing Practice (GMP) accreditation for their facilities and boasting dedicated hormone and non-hormone production lines. They also offer toll manufacturing services, demonstrating their expertise and experience in the industry. Notably, they have secured WHO prequalification (PQ) status for their Triclofem contraceptive, a testament to their quality and commitment to global healthcare. Their key focus areas include reproductive health, with a significant emphasis on contraceptives. They primarily manufacture solid dosage forms and injectables.