INNOVARE LABS PRIVATE LTD

Overview

INNOVARE LABS PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 15 active FDA Type II Drug Master Files, covering CINACALCET HYDROCHLORIDE; CLOPIDOGREL BISULFATE USP; DARUNAVIR; LEVETIRACETAM USP; METAXALONE USP; MOXIFLOXACIN HYDROCHLORIDE USP.

API / Drug Master Files

INNOVARE LABS PRIVATE LTD holds 15 active (15 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.

• ROSUVASTATIN CALCIUM USPActive2023-11-30
• RANOLAZINEActive2022-01-08
• METAXALONE USPActive2021-09-30
• TICAGRELORActive2021-08-10
• CINACALCET HYDROCHLORIDEActive2021-06-26
• RIVAROXABANActive2021-03-31
• DARUNAVIRActive2021-02-16
• TENOFOVIR (DRUG SUBSTANCE INTERMEDIATE)Active2020-12-29
• VORICONAZOLE USPActive2020-11-19
• MOXIFLOXACIN HYDROCHLORIDE USPActive2020-10-24
• PREGABALIN USPActive2020-08-21
• VILDAGLIPTINActive2020-06-30
• OSELTAMIVIR PHOSPHATE USPActive2020-04-01
• CLOPIDOGREL BISULFATE USPActive2020-03-28
• LEVETIRACETAM USPActive2020-02-22

FDA compliance signals

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