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Ropivacaine hydrochloride manufacturers

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Country of origin : India

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7 products found

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.

Manufacturer usually replies in 6 days

ropivacaine hydrochloride

Bags for injection/infusion 2 mg/ml, 5 mg/ml - 100 ml, 200 ml

Dossier type
US CTD
Dossier status
Under development
Country of origin
India
GMP approvals
FDA
Comments
ANDA / R &D Status: ANDA to be filed in Q2-2023, approval expected Q2-2024; 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.

Manufacturer usually replies in 6 days

ropivacaine hydrochloride

Injection 2 mg, 5 mg, 7.5 mg, 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #28571

This vertically integrated pharmaceutical company specializes in developing, manufacturing, and marketing a wide range of products across multiple therapeutic areas. Their key focus areas include oncology, blood-related products, nephrology, cardiology, gynecology, diabetology, and beta-lactam cephalosporins, along with vitamins and minerals. They also offer nutraceuticals and herbal products. The company's product portfolio encompasses various dosage forms such as injectables, suppositories, tablets, capsules, suspensions, syrups, ointments, emulsions, elixirs, ophthalmics, effervescent tablets, and dry powder. They have a strong global presence, participating in prominent industry events across regions like Europe and the Middle East. The company prioritizes quality and adheres to GMP certifications, further bolstering their commitment to delivering reliable pharmaceutical solutions.

Manufacturer usually replies in 1 days

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