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14 products found

neostigmine methylsulfate

Vials, injection 0.5 mg/ml, 1 mg/ml - 10 ml

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Manufacturer #15176

Manufacturer usually replies in 56 days

neostigmine methylsulfate

Solution for injection 0,5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO, INVIMA
Manufacturer #10726
This specialty biopharmaceutical company focuses on oncology and critical care medications, offering a diverse portfolio of over 650 product registrations across regions including the EU, North America, and Asia. Their expertise includes developing innovative, cost-effective drug delivery systems like microspheres, liposomes, and nanoparticles. They are recognized for manufacturing high-quality products adhering to global standards such as WHO-GMP and Schedule M certifications. Key therapy areas include oncology (with a focus on oral medications) and critical care, encompassing cardiovascular and anesthesia segments. The company has launched several first-in-market products and continues to expand its presence globally.

neostigmine methylsulfate

Vials, injection 0.5 mg/ml, 1 mg/ml - 10 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: "Bloxiverz / Eclat"; Indication: Cholinesterase inhibitor, indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery;
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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