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Country of origin : India
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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.

theophylline + etofylline

Tablets 150 mg, 300 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
Myanmar, Sri Lanka
Manufacturer #23786
Founded in the 1950s with nearly seven decades of pharmaceutical leadership, this integrated pharma company is among the top players in its home market. Rx and OTC portfolio spans branded generics, biosimilars, APIs, and novel drugs across oncology, metabolic, cardiac, and infectious disease therapy areas. US FDA and EU-GMP approved facilities operate across multiple continents.

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.

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