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Montelukast sodium manufacturers

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Country of origin : India
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montelukast sodium

Tablets 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #20110
This pharmaceutical contract manufacturer specializes in a wide range of dosage forms including tablets, capsules, injections, syrups, suspensions, and eye/ear drops. They operate across numerous key regions globally, with a strong presence in Africa, Asia Pacific, North America, and the EU. Their expertise spans several therapy areas such as generics, rare diseases, nutraceuticals, and functional ingredients. The company boasts several patented products and holds GMP certifications, ensuring high-quality manufacturing standards. They are known for their commitment to research and development, constantly innovating with new ingredients like Fibronectin for wound healing.

montelukast sodium

Tablets 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #31580

Established in 1990, this Indian manufacturer employs approximately 3,065 individuals and specializes in developing and manufacturing IP-led niche finished dosage formulations. As a CTD dossier owner and manufacturer, it holds GMP certifications from major regulatory authorities, including the US FDA, EU-GMP, Health Canada, and UK MHRA, ensuring compliance with stringent international quality standards. The company operates eight manufacturing units across India, Singapore, Italy, the United States, and Kenya, producing a range of products, including soft gelatin capsules, tablets, and ointments. As a CTD dossier owner and manufacturer, its products are distributed in over 100 countries worldwide.

fexofenadine + montelukast sodium

Tablets 120 mg + 10 mg, 180 mg + 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #36397

Established in 2009, this manufacturer specializes in active pharmaceutical ingredients (APIs) and finished formulations, including tablets, capsules, and liquid orals. As a CTD dossier owner and manufacturer, it holds GMP certifications from international regulatory authorities, including the U.S. FDA and EU GMP, ensuring compliance with stringent quality standards. The manufacturer operates state-of-the-art production facilities in Vadodara and Vapi, India, adhering to rigorous GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed across various regions, including Europe, East Asia, South America, and the Middle East. With a strong focus on research and development, the manufacturer is committed to delivering high-quality pharmaceutical solutions to meet global healthcare needs.

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