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Apalutamide manufacturers

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Country of origin : India

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4 products found

apalutamide

Tablets 60 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA, EU GMP
Manufacturer #18975
This contract development and manufacturing organization (CDMO) specializes in producing a wide range of pharmaceutical products, including prescription medications, over-the-counter drugs, tablets, and capsules. They cater to clients across the globe, with a strong presence in regions like the EU and North America. Their expertise spans several key therapy areas, utilizing various dosage forms such as oral solid dose. They prioritize quality assurance, adhering to strict GMP certifications and holding numerous product patents.

Manufacturer usually replies in 16 days

apalutamide

Tablets 60 mg, 240 mg

Dossier type
US CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA
Comments
Reference product: Erleada®
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 24 days

apalutamide

Tablets 75 mg, 100 mg, 150 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP, PICS, COFEPRIS, MHRA, Canada, South Africa, United Arab Emirates, Turkey
Manufacturer #36255

Established in 2013, this manufacturer specializes in oncology, focusing on the research, manufacturing, and marketing of high-quality specialty formulations. As a CTD dossier owner and manufacturer, it holds GMP certifications from international regulatory authorities, including USFDA, MHRA, and PIC/S, ensuring compliance with stringent quality standards. The manufacturer operates a state-of-the-art facility in Hyderabad, India, designed to meet global regulatory requirements. As a CTD dossier owner and manufacturer, its products are distributed worldwide. With a commitment to innovation and quality, the manufacturer aims to provide the best options to oncologists and their patients.

Manufacturer usually replies in 32 days

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