PHARMAZELL INDIA PRIVATE LTD

Overview

PHARMAZELL INDIA PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 19 active FDA Type II Drug Master Files, covering ABIRATERONE ACETATE; ATAZANAVIR SULPHATE [DRUG SUBSTANCE (NON-STERILE)]; CAPECITABINE USP [DRUG SUBSTANCE (NON-STERILE)]; CELECOXIB USP; DASATINIB; DASATINIB [DRUG SUBSTANCE (NON-STERILE)].

API / Drug Master Files

PHARMAZELL INDIA PRIVATE LTD holds 19 active (24 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.

• OLAPARIB (FORM-H)Active2025-06-30
• IBRUTINIB (FORM-A)Active2024-12-12
• GEFITINIBActive2024-09-03
• DASATINIBActive2023-01-16
• ENZALUTAMIDEActive2022-12-22
• ABIRATERONE ACETATEActive2022-01-06
• SUNITINIB MALATEActive2021-10-12
• ERLOTINIB HYDROCHLORIDE [DRUG SUBSTANCE (NON-STERILE)]Active2021-06-04
• DASATINIB [DRUG SUBSTANCE (NON-STERILE)]Active2021-06-02
• TENOFOVIR ALAFENAMIDE FUMARATE [DRUG SUBSTANCE (NON-STERILE)].Active2020-08-12
• ERLOTINIB HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE)Active2018-09-29
• PALBOCICLIB (NON-STERILE DRUG SUBSTANCE)Active2018-08-14
• PAZOPANIB HCL (NON-STERILE DRUG SUBSTANCE)Active2018-07-28
• PEMETREXED DISODIUM HEMIPENTA HYDRATE [DRUG SUBSTANCE (NON-STERILE)]Active2018-02-28
• ATAZANAVIR SULPHATE [DRUG SUBSTANCE (NON-STERILE)]Active2014-12-23

Showing 15 of 24 Drug Master Files.

FDA compliance signals

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