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Country of origin : India
None products found

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.

Manufacturer usually replies in 2 days

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.

Manufacturer usually replies in 13 days

promethazine

Injection 25 mg/ml, 50 mg/ml

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
FDA
Registered in
United States
MAs available in
United States
Comments
ANDA for divestment
Manufacturer #3127
A multinational pharmaceutical manufacturer with operations in formulations, biopharmaceuticals, active pharmaceutical ingredients (APIs) and vaccines, producing a wide spectrum of pharmaceutical products. The company’s manufacturing units have obtained international regulatory certifications, including an EU‐GMP Compliance Certificate issued by a European competent authority for an active substances facility.

Manufacturer usually replies in 33 days

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