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trifluoperazine

Syrup 1 mg/5 ml, 5 mg/5 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
MHRA
Manufacturer #12170
This company has been involved in the development, production, and regulatory support of generic pharmaceuticals for over 20+ years and has offices at various locations. They have more than 20+ generic medications registered across Europe. The items are sold on more than five continents.

Manufacturer usually replies in 28 days

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 28 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 16 days

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