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Country of origin : India

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leuprolide acetate

Injection 3.75 mg, 7.5 mg, 11.25 mg, 15 mg, 22.5 mg, 30 mg, 45 mg

Dossier type
US CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA
Comments
Reference product: Lupron Depo. ,Abbvie Endocrine Inc
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 28 days

leuprolide acetate

Vials, lyophilized 11.25 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #38728

Established in 2012, this Manufacturer is a CTD dossier owner and manufacturer and GMP manufacturer with products sold in over 39 countries across four continents. With multiple WHO-GMP and other regulatory approvals (e.g., Ghana FDA, Philippines FDA, Kenya PBB, Tanzania TFDA, Nigeria NAFDAC), it operates several finished dosage and R&D production lines (tablets, capsules, injectables, liquids, softgels, effervescent, suppositories). As a CTD dossier owner and manufacturer, it supports regulatory filings worldwide. Headquartered in India and employing a global workforce, it serves diverse markets as a CTD dossier owner and manufacturer and GMP manufacturer.

leuprolide acetate

Injection, lyophilized 3.75 mg, 11.25 mg, 22.5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP, PICS, MHRA, WHO
Manufacturer #38657

The company is a pharmaceutical manufacturer engaged in the development, production and export of a range of pharmaceutical products across key therapeutic segments including oncology, critical care and lifesaving medicines, operating with certified manufacturing capabilities and global distribution networks to supply these pharmaceutical products to international healthcare markets.

Manufacturer usually replies in 7 days

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