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Country of origin : India

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procainamide hydrochloride

Injection 100 mg/ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP, PICS, MHRA, WHO
Manufacturer #38657

The company is a pharmaceutical manufacturer engaged in the development, production and export of a range of pharmaceutical products across key therapeutic segments including oncology, critical care and lifesaving medicines, operating with certified manufacturing capabilities and global distribution networks to supply these pharmaceutical products to international healthcare markets.

Manufacturer usually replies in 7 days

procainamide hydrochloride

Injection 100 mg/ml

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 21 days

procainamide hydrochloride

Vials, injection 100 mg/ml, 500 mg/ml - 2 ml, 10 ml

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
FDA
Comments
ANDA / R &D Status: Filed, under approval; US RLD / Holder: "Pronestyl / Apothecon Inc."; Indication: Antiarrhythmic Agent. Used to treat irregular heartbeats and to slow an overactive heart ;
Manufacturer #8216
This fast-growing pharmaceutical company boasts a dominant presence in Latin America, Francophone Africa, and a growing footprint in regulated markets like the EU and North America. Founded in 1990, it initially focused on ointments and creams before expanding its product range significantly. With over 4,000 global product licenses, they cater primarily to the "Bottom of the Pyramid" through their owned distribution networks. The company's manufacturing facility holds multiple certifications including US FDA approval (with three successful inspections since 2016), EU-GMP, ANVISA-Brazil, INVIMA-Colombia, and COFEPRIS-Mexico. They prioritize innovation with a significant portion of their earnings invested in research and development of safe and effective products across various dosage forms. Key therapy areas are not specified.

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