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Procainamide hydrochloride manufacturers

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Country of origin : India

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6 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
WHO
Manufacturer #19639

This globally operating pharmaceutical company focuses on developing and manufacturing a broad range of affordable medications. They specialize in both prescription and over-the-counter drugs, including oncology treatments, antibacterials, injectables (both specialty and large volume), ophthalmic products, dermatological preparations, and veterinary pharmaceuticals. Their product portfolio also includes unique niche drugs and orphan products, showcasing their commitment to addressing diverse medical needs. The company boasts state-of-the-art manufacturing facilities located across several regions, adhering to strict quality standards recognized by international regulatory bodies like the WHO GMP, US FDA, and MCC. Their extensive global reach spans over 45 countries in Asia, Africa, Latin America, CIS, Europe, Australia, and the Pacific Ocean. The company's focus on research and development, coupled with its global manufacturing capabilities and commitment to quality, positions them as a key player in the international pharmaceutical market.

Manufacturer usually replies in 20 days

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