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Relugolix manufacturers

7 products found

Filters

7 products found

relugolix

Tablets, film coated 120 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Ref. Orgovyx®, Myfembree® (US) / Ryeqo®, (EU), Myovant Sciences
Manufacturer #8822
A pharmaceutical manufacturer based in Europe that has been active in 60+ countries selling its products in Europe, North America, LATAM, MENA, and Asia for 50+ years. The main therapeutic areas include CNS, ophthalmology, and dermatology. Main dosage forms include sterile and solid oral dosage forms. The company's production lines are cGMP-compliant. The company possesses branches in Europe, North America, and Asia.

Manufacturer usually replies in 16 days

relugolix

Tablets 120 mg

Dossier type
US CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA
Comments
Reference product: Orgovyx®
Manufacturer #15189
The company, which was founded in 1989, is involved in developing, manufacturing, and distributing a wide range of formulations for anti-infectives, cardiovascular, anti-diabetic, dermatological, and hormone treatment. The corporation has a global presence in 170 + countries, 60+ WHO-prequalified medications, and 3700+ product registrations.

relugolix + estradiol + norethisterone

Tablets, immediate release (IR) 40 mg + 1 mg + 0.5 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.

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