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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

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

Injection 5 mg/ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
FDA, EU GMP
Manufacturer #13072
This pharmaceutical company, established in 1958, boasts a long history and operates across multiple regions, including Europe and North America. They specialize in the production of prescription medications, with a focus on three key therapy areas: oncology, immunology, and dermatology. Their principal dosage forms include tablets, capsules, and topical solutions. The company possesses GMP certifications and holds patents for several product innovations. With three production facilities and a logistics center, they prioritize efficiency and international expansion, aiming to become a global leader in the pharmaceutical industry.

Manufacturer usually replies in 16 days

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