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.

Core services & business areas

Active pharmaceutical ingredients supplied

Substances SYN-TECH CHEM AND PHARM CO LTD is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

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
• NAFTOPIDILActive2012-09-26
• GRANISETRON HYDROCHLORIDE USPActive2012-09-26
• 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.