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revefenacin

Inhalation solution 175 mcg/3 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
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 31 days

revefenacin

Nebuliser solution 175 mcg - 3 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
ANVISA, TGA, INVIMA
Manufacturer #36629

Established in 1993, this manufacturer employs over 1,100 staff and operates advanced production lines for metered dose inhalers, nasal sprays, dry powder inhalers, and nebulizer solutions. As a CTD dossier owner and manufacturer, it holds GMP approvals from more than 20 countries, including Australia. The manufacturer is recognized as a CTD dossier owner and manufacturer, and its products are distributed in over 90 countries worldwide. With a focus on innovation, the manufacturer is a CTD dossier owner and manufacturer, dedicated to developing high-end generic drugs

Manufacturer usually replies in 30 days

revefenacin

Nebuliser solution 175 mcg - 3 ml

Dossier type
CTD
Dossier status
Under development
Country of origin
China
GMP approvals
FDA, China
Manufacturer #20131

This fully integrated specialty pharmaceutical company focuses on researching, manufacturing, and marketing respiratory drug products globally. Their therapeutic areas include allergic rhinitis, asthma, COPD, respiratory infections, pulmonary fibrosis, and pulmonary hypertension. They offer various dosage forms, including inhalation sprays (SMI), metered-dose inhalers (MDI), dry powder inhalers (DPI), nebulizations, nasal sprays, and liposomes. The company boasts over 30 patents and a team of more than 100 R&D personnel. They have received recognition as a top employer in their region and secured significant funding to support the development of high-end inhalation products. Their operations extend across key regions like the EU and North America.

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