SYN-TECH CHEM AND PHARM CO LTD

Overview

SYN-TECH CHEM AND PHARM CO LTD is an active pharmaceutical ingredient (API) supplier with 20 active FDA Type II Drug Master Files, covering CHLORZOXAZONE USP; CROTAMITON USP; DICLOFENAC EPOLAMINE; DICLOFENAC POTASSIUM USP; DICLOFENAC SODIUM USP; GRANISETRON.

API / Drug Master Files

SYN-TECH CHEM AND PHARM CO LTD holds 20 active (26 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• TIMOLOL MALEATE (TMM)Active2022-06-16
• LAMOTRIGINE USPActive2016-02-02
• MIRTAZAPINE USPActive2015-08-31
• RIZATRIPTAN BENZOATE USPActive2014-09-08
• ZOLMITRIPTANActive2013-12-11
• GRANISETRON HYDROCHLORIDE USPActive2012-09-26
• NAFTOPIDILActive2012-09-26
• CROTAMITON USPActive2012-08-29
• RILUZOLEActive2012-06-08
• GRANISETRONActive2012-04-16
• TOLPERISONE HYDROCHLORIDEActive2011-10-31
• DICLOFENAC EPOLAMINEActive2011-05-05
• METAXALONE USPActive2011-02-04
• RABEPRAZOLE SODIUMActive2009-12-15
• TIMOLOL MALEATE USPActive2009-07-31

Showing 15 of 26 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to SYN-TECH CHEM AND PHARM CO LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.