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Country of origin : India
None products found

trifluoperazine

Oral solution 1 mg/5 ml, 5 mg/5 ml

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Comments
Reference product: Stelazine®
Manufacturer #15189
The company, which was founded in 1989, is involved in developing, manufacturing, and distributing a wide range of formulations for anti-infectives, cardiovascular, anti-diabetic, dermatological, and hormone treatment. The corporation has a global presence in 170 + countries, 60+ WHO-prequalified medications, and 3700+ product registrations.

Manufacturer usually replies in 29 days

trifluoperazine + trihexyphenidyl hydrochloride

Tablets 2.5 mg + 2 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #38728

Established in 2012, this Manufacturer is a CTD dossier owner and manufacturer and GMP manufacturer with products sold in over 39 countries across four continents. With multiple WHO-GMP and other regulatory approvals (e.g., Ghana FDA, Philippines FDA, Kenya PBB, Tanzania TFDA, Nigeria NAFDAC), it operates several finished dosage and R&D production lines (tablets, capsules, injectables, liquids, softgels, effervescent, suppositories). As a CTD dossier owner and manufacturer, it supports regulatory filings worldwide. Headquartered in India and employing a global workforce, it serves diverse markets as a CTD dossier owner and manufacturer and GMP manufacturer.

Manufacturer usually replies in 22 days

trifluoperazine

Capsules 5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #18338
This company has a strong presence in the pharmaceutical industry, operating for over three decades. They specialize in manufacturing a wide range of prescription and over-the-counter medications, including specialty products for various therapeutic areas such as cardiovascular health, pain management, and infectious diseases. Their production lines include solid, liquid, and topical dosage forms, all adhering to strict GMP standards, including EU and USFDA approvals. The company has a global presence and exports to various regions, particularly in Asia. They have a strong track record of providing high-quality and affordable medicines.

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