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artether

Injection 150 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 14 days

artether

Injection 75 mg, 150 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #2303
A pharmaceutical manufacturer with over 25 years of experience that develops and produces fixed-dose and single-entity generic and specialty pharmaceutical products. The company offers an extensive range of injectable dosage forms, including parenterals, and also manufactures oral solids. Its facilities operate under recognised international quality certifications such as EU-GMP, ANVISA, PIC/S and TGA approvals, supporting reliable large-scale production of pharmaceutical products for global export while emphasizing efficacy, affordability and consistent quality.

Manufacturer usually replies in 19 days

artether

Injection 150 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #19828

This fully integrated transnational pharmaceutical company focuses on developing high-quality formulations to address unmet medical needs. They boast a strong presence in the Indian market and expanding global reach, offering both branded and generic medications, as well as APIs. Their state-of-the-art WHO-GMP certified production facility in Mehsana is equipped to manufacture a wide range of dosage forms, including tablets, capsules, liquids, creams, ointments, and injectables. The company prioritizes innovation, with a pipeline of new products targeting areas like opioid addiction treatment. Key therapy areas include antibacterials, anti-infectives, anti-diarrheals, pain management, anemia management, and opioid de-addiction. They hold product patents and adhere to stringent regulatory guidelines from authorities like the USFDA, EDQM, MHRA, and MCA. Their products are distributed across various regions, including the EU and North America.

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