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Country of origin : India
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pholcodine + promethazine

Syrup 1,5mg+1,5mg/5ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #18567
This pharmaceutical company boasts a four-decade history of providing quality liquid formulations across a range of therapeutic areas. With a strong focus on innovation and ethical practices, it operates multiple manufacturing facilities adhering to GMP certifications, including USFDA, WHO-GMP, and cGMP. Their product portfolio encompasses prescription medications, over-the-counter drugs, and medical devices, served through a pan-India presence with plans for expansion into new markets in the EU and North America. Key therapy areas include pediatrics and dermatology, utilizing diverse dosage forms such as liquids and topical applications. The company also holds several product patents and partners with select institutions to manufacture high-quality pharmaceutical products globally.

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promethazine

Injection 25 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.

promethazine

Tablets 10 mg, 25 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP, WHO
Manufacturer #36540

Established in January 2010, this manufacturer specializes in the contract manufacturing of oral solid dosage forms for both pharmaceuticals and nutraceuticals. As a CTD dossier owner and manufacturer, it holds GMP approvals, ensuring compliance with international quality standards. The manufacturer operates advanced production lines for tablets, capsules, and sachets, adhering to stringent GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed in various countries worldwide. With a dedicated team experienced in formulation development, the manufacturer is committed to delivering high-quality and regulatory-compliant products

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