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Ropivacaine hydrochloride manufacturers

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Country of origin : India

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6 products found

ropivacaine hydrochloride

Injection 0.20%, 0.75%

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #17417
This innovative life sciences company specializes in developing, manufacturing, and marketing a range of life-saving critical care drugs and other pharmaceuticals. They focus on addressing unmet medical needs across various therapeutic areas including anesthesiology, cardiology, gastroenterology, urology, gynecology, oncology, and pediatrics. The company has manufacturing facilities strategically located in different regions and boasts a robust R&D division dedicated to innovation. They hold multiple product patents and GMP certifications, ensuring high-quality standards. Their portfolio includes both prescription medications and animal health products, targeting key regions such as North America, the EU, and Asia.

ropivacaine hydrochloride

Injection 2 mg/mL, 5 mg/mL and 10 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

ropivacaine hydrochloride

Vials, injection 2 mg/ml, 5 mg/ml, 10 mg/ml - 20 ml, 30 ml

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
FDA
Comments
ANDA / R &D Status: Approved; US RLD / Holder: "Naropin / Fresenius Kabi"; Indication: Local Anesthetic;
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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