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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 45 days

norethisterone acetate

Tablets, extended release (ER) 10mg, 15mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #18510
A professionally organised pharmaceutical manufacturer focused on formulation manufacturing and ethical promotion of pharmaceutical products, supported by an extensive field force and nationwide logistics network. The company combines in-house production of key dosage forms with structured marketing, defined core values such as integrity, compliance and customer orientation, and a broad portfolio of pharmaceutical products aimed at serving both retail and institutional healthcare segments.

Manufacturer usually replies in 50 days

norethisterone acetate

Tablets 5mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #18510
A professionally organised pharmaceutical manufacturer focused on formulation manufacturing and ethical promotion of pharmaceutical products, supported by an extensive field force and nationwide logistics network. The company combines in-house production of key dosage forms with structured marketing, defined core values such as integrity, compliance and customer orientation, and a broad portfolio of pharmaceutical products aimed at serving both retail and institutional healthcare segments.

Manufacturer usually replies in 50 days

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