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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
A sterile-focused pharmaceutical manufacturer specialising in the development and commercial supply of liquid and lyophilised injectable pharmaceutical products in vials and ampoules. Its advanced manufacturing facility is described as compliant with international regulatory agencies, and the company highlights cGMP approvals and renewals from authorities such as the US FDA, UK MHRA, ANVISA, INVIMA and EU GMP bodies, supporting high-volume capacity and reliable global supply of injectable pharmaceutical products.

Manufacturer usually replies in 57 days

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.

neostigmine methylsulfate

Injection 0.5 mg/ml, 2.5 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 22 days

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