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Norethisterone acetate manufacturers

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norethisterone acetate

Tablets, prolonged release (PR) 10 mg, 15 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #36201

Established in 2003, this manufacturer specializes in developing, manufacturing, and marketing a diverse portfolio of pharmaceutical products. As a CTD dossier owner and manufacturer, it holds WHO-GMP certification and complies with various international regulatory standards, including EFDA Ethiopia, PPB Kenya, FDA Philippines, NAFDAC Nigeria, DPM Ivory Coast, MOH Cambodia, and NMHPRA Afghanistan. The manufacturer operates two state-of-the-art WHO-GMP manufacturing units producing general category formulations such as tablets, oral liquids, capsules, and sachets. A new facility under its sister concern, operational since May, is compliant with USFDA, PIC/S, and UKMHRA guidelines. As a CTD dossier owner and manufacturer, its products are distributed across multiple countries worldwide.

Manufacturer usually replies in 37 days

norethisterone acetate

Tablets 5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Taiwan
GMP approvals
PICS
Manufacturer #20576

Established in 1961, this Manufacturer is a CTD dossier owner and manufacturer based in Yunlin County, Taiwan. With over six decades of experience, it operates GMP-certified facilities compliant with PIC/S GMP standards, producing a diverse range of products including tablets, capsules, oral liquids, external liquids, and health foods. As a GMP manufacturer, it holds certifications such as the Accreditation Certificate of Foreign Drug Manufacturer approved by Japan's Ministry of Health, Labour and Welfare, and a valid CGMP certificate from the Philippines FDA, ensuring adherence to international quality standards. The Manufacturer's products are distributed across various countries and regions worldwide. Its commitment to excellence as a CTD dossier owner and manufacturer and GMP manufacturer solidifies its reputation in the global pharmaceutical market.​

 

Manufacturer usually replies in 27 days

norethisterone acetate

Tablets 5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Taiwan
GMP approvals
PICS
Manufacturer #20548

It is PIC/S certificated company, having more than 45-year experience of in manufacturing pharma products. The company is dedicated to providing superior products and services to valued clients. The company on the other hand is researching and developing new BA and BE products to meet the market trend in the future.

Manufacturer usually replies in 17 days

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