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acalabrutinib

Tablets 100 mg

Dossier type
US CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
FDA, EU GMP
Manufacturer #276
This company is a global manufacturer and distributor of high-quality generic medicines, with a mission to make these medicines accessible to patients worldwide. It operates in several regions, including Europe and Latin America, and emphasizes strong partnerships within the pharmaceutical industry to expand its reach. The company is committed to sustainability and transparency, following Environmental, Social, and Governance (ESG) principles. They regularly engage in major industry events, highlighting their dedication to networking and maintaining a leading position in the market for generic medications.

Manufacturer usually replies in 18 days

acalabrutinib

Tablets, film coated 100 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Turkey
GMP approvals
FDA, EU GMP
Comments
PRODUCT PROTECTION EXPIRATION (EU): Nov 2035. In-House API
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 15 days

acalabrutinib

Tablets 100 mg

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

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