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Country of origin : India
None products found

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.

Manufacturer usually replies in 8 days

levocetirizine dihydrochloride + montelukast sodium

Syrup 2.5 mg + 4 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #18256
This pharmaceutical company specializes in a wide range of products including prescription medications, over-the-counter drugs, and supplements. They focus on key therapy areas such as anti-infectives, anesthesiology, gastroenterology, pain management, nephrology, gynecology, and vitamin/mineral nutrition. Their manufacturing facilities are equipped to produce various dosage forms and hold relevant GMP certifications. The company has a strong presence in Asia with plans for international expansion. They actively pursue product development and hold patents for key medications.

Manufacturer usually replies in 26 days

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.

Manufacturer usually replies in 30 days

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