Nusinersen manufacturers

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Vials 2.4 mg/ml - 5 ml

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP, China
Comments
Ref: Spinraza®
Manufacturer #252

This company is a leading player in the pharmaceutical industry, boasting decades of experience in research, development, and manufacturing. They specialize in the production of a wide range of pharmaceutical ingredients (APIs) and finished dosage forms (FDFs) for both human and veterinary use. Their product portfolio spans multiple therapeutic areas, including but not limited to, oncology, cardiology, and other essential therapeutic categories. They offer a comprehensive range of services, including contract manufacturing (CMO) and the production of over-the-counter (OTC) products. The company holds EU and US GMP approvals for its production lines, ensuring adherence to rigorous quality standards. Their production lines encompass various dosage forms, including solids, liquids, and injectables. Their global presence extends across Europe and North America, with a network of 10 manufacturing facilities. They have a strong commitment to research and development, with dedicated teams focusing on innovative solutions and advancements in the pharmaceutical field.

nusinersen

Solution for injection 12 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Unavailable markets
Vietnam
Comments
Intrathecal Solution
Manufacturer #21467

This global pharmaceutical company is dedicated to improving patients' lives through high-quality, differentiated products and services. They leverage a collaborative network to achieve success in key regions like the EU and North America. Their focus areas include women's health, infectious diseases, and potentially other therapeutic areas based on their recent approvals and launches. They produce prescription medications (including injectables) and tablets, demonstrating expertise in various dosage forms. The company holds GMP certifications and boasts successful product patents, solidifying its commitment to quality and innovation.

nusinersen

Vials 12 mg - 5 ml

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.

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