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etofylline + theophylline

Injection 84.7 mg + 25.3 mg - 2 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #35915

Established in 2007, this family-owned manufacturer specializes in pharmaceutical formulations, offering over 500 products across various dosage forms, including tablets, capsules, dry syrups, ointments, dry injections, and liquid orals. As a CTD dossier owner and manufacturer, it holds WHO-cGMP certification, ensuring compliance with stringent international quality standards. The manufacturer operates advanced production lines with capacities such as 3,600 million tablets, 1,800 million capsules, 240 million liquid injections in ampoules, and 70 million dry powder injections per annum, adhering to rigorous GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed across multiple countries worldwide.

Manufacturer usually replies in 7 days

theophylline

Tablets, sustained release (SR) 200 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

theophylline

Tablets, extended release (ER) 300 mg, 450 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 33 days

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