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Riociguat manufacturers

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riociguat

Tablets, film coated 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg

Dossier type
EU CTD
Dossier status
Ready to file
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

riociguat

Tablets, film coated 0.5mg, 1mg, 1.5mg, 2mg, 2.5mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
MAs available in
France , Germany
Comments
MA status in France 2027; MA status in Germany 2027.
Manufacturer #673

A pharmaceutical manufacturer based in the EU that has been active in 60+ countries selling its products in Europe, CIS, and Oceania for 40+ years. Key production lines are Rx and OTC. Main therapeutic areas include neurology, cardiology, and infectiology. The company's production lines are EU GMP-compliant. The company possesses branches in 10+ countries in Europe and CIS.

Manufacturer usually replies in 17 days

riociguat

Tablets 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Unavailable markets
Costa Rica , Vietnam
MAs available in
Finland , Iceland , Malta
Comments
EU DCP approved
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.

Manufacturer usually replies in 19 days

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