Leuprolide acetate manufacturers

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leuprolide acetate

Injection 14 mg/2.8ml

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
FDA
Manufacturer #23786
Founded in the 1950s with nearly seven decades of pharmaceutical leadership, this integrated pharma company is among the top players in its home market. Rx and OTC portfolio spans branded generics, biosimilars, APIs, and novel drugs across oncology, metabolic, cardiac, and infectious disease therapy areas. US FDA and EU-GMP approved facilities operate across multiple continents.

leuprolide acetate

Injection 5 mg/ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
FDA, EU GMP
Unavailable markets
Iraq
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.

leuprolide acetate

Injection 11.25 mg, 3.75 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Comments
Depot for injection
Manufacturer #40168

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