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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.

Manufacturer usually replies in 29 days

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
India
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

relugolix

Tablets, film coated 60 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Argentina
GMP approvals
PICS
Available for
Licensing with supply, Distribution only
Manufacturer #15733
One of the leading manufacturers in cosmetic and medicinal products in the South American Continent. The company has been committed since 1990-is to developing and manufacturing high-quality products that allow healing and improve someone’s life. They are a major exporter of its therapies to different regions such as Latin America and Asia. Medicine is manufactured for pain, gastroenterology, hepatology, and cardiology.

Manufacturer usually replies in 41 days

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