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Flucytosine manufacturers

4 products found

Filters

4 products found

flucytosine

Capsule 250mg, 500mg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
United States
GMP approvals
FDA
Manufacturer #19592
This privately held specialty pharmaceutical company develops, manufactures, and markets both generic and branded products, often focusing on challenging formulations. They operate across key regions including North America and the EU. Their product portfolio includes prescription medications and over-the-counter drugs, with a particular emphasis on difficult-to-formulate generics. Key therapy areas include [Therapy area 1], [Therapy area 2] , and [Therapy area 3]. They utilize proprietary systems to optimize drug solubility, bioavailability, and stability, reflected in principal dosage forms such as tablets. While specific GMP certifications and product patents are not mentioned, they highlight a commitment to quality and innovation, as demonstrated by product relaunches and voluntary recall procedures for ensuring product safety.

flucytosine

Capsules 250 mg, 500 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #31580

Established in 1990, this Indian manufacturer employs approximately 3,065 individuals and specializes in developing and manufacturing IP-led niche finished dosage formulations. As a CTD dossier owner and manufacturer, it holds GMP certifications from major regulatory authorities, including the US FDA, EU-GMP, Health Canada, and UK MHRA, ensuring compliance with stringent international quality standards. The company operates eight manufacturing units across India, Singapore, Italy, the United States, and Kenya, producing a range of products, including soft gelatin capsules, tablets, and ointments. As a CTD dossier owner and manufacturer, its products are distributed in over 100 countries worldwide.

Manufacturer usually replies in 31 days

flucytosine

Tablets 250 mg, 500 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP, WHO
Manufacturer #9406

Manufacturer usually replies in 24 days

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