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Procainamide hydrochloride manufacturers

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Country of origin : India

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7 products found

procainamide hydrochloride

Injection 100 mg/ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #2303

Manufacturer usually replies in 23 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.

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

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