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Abemaciclib manufacturers

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abemaciclib

Tablets, film coated 50 mg, 100 mg, 150 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

abemaciclib

Tablets, film coated 50 mg, 100 mg, 150 mg, 200 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

abemaciclib

Tablets, film coated 50 mg, 100 mg, 150 mg, 200 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #622
This pharmaceutical company boasts a global reach, with products distributed to over 100 countries. They have a diverse portfolio encompassing over 650 products, primarily focusing on cardiovascular and central nervous system treatments. With a history spanning over a century, they are a well-established player in the industry, demonstrating a strong commitment to innovation and research. Their dedication to R&D is evident in their significant investments and the numerous patents they hold, showcasing their dedication to improving healthcare outcomes. They manufacture both Rx and OTC products, along with active pharmaceutical ingredients, and have a strong track record in the European Union and North America, having achieved relevant GMP approvals for their production lines.

Manufacturer usually replies in 20 days

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