CHROMO LABORATORIES INDIA PRIVATE LTD

Overview

CHROMO LABORATORIES INDIA PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 44 active FDA Type II Drug Master Files, covering ABACAVIR SULFATE USP; ARIPIPRAZOLE USP; ARMODAFINIL; ATAZANAVIR SULFATE USP; ATORVASTATIN CALCIUM TRIHYDRATE USP; AZILSARTAN KAMEDOXOMIL.

API / Drug Master Files

CHROMO LABORATORIES INDIA PRIVATE LTD holds 44 active (45 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.

• POSACONAZOLEActive2025-08-23
• KETOROLAC TROMETHAMINE USPActive2025-04-24
• LACOSAMIDE USPActive2025-03-18
• ARMODAFINILActive2025-03-01
• ARIPIPRAZOLE USPActive2025-02-04
• SITAGLIPTIN PHOSPHATE MONOHYDRATE USPActive2024-11-17
• AZILSARTAN KAMEDOXOMILActive2024-10-04
• DARUNAVIR ETHANOLATEActive2024-09-30
• ABACAVIR SULFATE USPActive2024-08-14
• LEVOFLOXACIN HEMIHYDRATE USPActive2024-07-30
• SACUBITRIL VALSARTAN TRISODIUM HEMIPENTAHYDRATEActive2024-06-06
• OMEPRAZOLE MAGNESIUM USPActive2024-04-26
• OMEPRAZOLEActive2024-04-22
• PREGABALIN USPActive2023-08-23
• ZIPRASIDONE MESILATE TRIHYDRATEActive2023-05-15

Showing 15 of 45 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to CHROMO LABORATORIES INDIA PRIVATE LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.