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3 products found

inclisiran

Solution for injection 284 mg/1.5 ml

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #17457
In the past fifty years, the company has reached significant milestones—a result of enviable performance, strict adherence to the highest ethical and operational standards, and full compliance with global regulatory authorities. During this journey, they have emerged as one of the leading in-house development partners based in Europe, specializing in the development, registration, manufacturing, and life-cycle management of highly complex pharmaceutical technologies and generic formulations.

Manufacturer usually replies in 40 days

inclisiran

Injection, pre-filled syringe 189 mg/ml

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
REFERENCE PRODUCT: Leqvio® Novartis
Manufacturer #8822
A pharmaceutical manufacturer based in Europe that has been active in 60+ countries selling its products in Europe, North America, LATAM, MENA, and Asia for 50+ years. The main therapeutic areas include CNS, ophthalmology, and dermatology. Main dosage forms include sterile and solid oral dosage forms. The company's production lines are cGMP-compliant. The company possesses branches in Europe, North America, and Asia.

Manufacturer usually replies in 27 days

inclisiran

Injection, pre-filled syringe 284 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

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