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Apalutamide manufacturers

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apalutamide

Tablets, film coated 60 mg, 240 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #260
Pharmaceutical manufacturer operating in the EU for 50+ years. Activities include scientific development, manufacturing, out-licensing, marketing, and distribution of high-quality generic medicines. The company owns several production facilities that all comply with EU GMP requirements. Key dosage forms include conventional solids, cytostatic injectables, and cytostatic orals. The company holds an in-house R&D and Intellectual property business unit, as well as a regulatory affairs team that prepares CTD dossiers and maintains direct contact with regulatory agencies worldwide. The portfolio includes more than three thousand MA sets approved in the EU while hundreds of MA are in progress. Key therapy lines are cardiovascular, CNS, diabetes, immunology, oncology, and more. The company is active in nearly 100 countries worldwide, selling its products in Africa, Asia, Australia, Europe, LATAM, and the Middle East.

Manufacturer usually replies in 15 days

apalutamide

Tablets, film coated 60 mg, 240 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Iceland
GMP approvals
EU GMP
Manufacturer #28915

This company specializes in generic pharmaceuticals within the EU region. They offer out-licensing and contract manufacturing services to pharmaceutical companies seeking high-quality production from a reliable European partner. Their facility utilizes green energy sources, highlighting their commitment to sustainability. While specific therapy areas and product details are not provided, they likely focus on various dosage forms common in generic pharmaceuticals. The company emphasizes its skilled workforce and dedication to employee well-being.

Manufacturer usually replies in 21 days

apalutamide

Capsules 60 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #10856

It is a pharmaceutical manufacturing company offering unique services covering a strategic base for the development of generics and ‘Day 1’ launch into the EU and beyond. Established in the 2000s, with a considerable investment of founding energy, expertise, and resources. The company boasts a state-of-the-art facility, infrastructure, and high-end equipment, dedicated to high potency ‘contained production’ to supply a range of therapeutic products for world markets.

Manufacturer usually replies in 29 days

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