Qilu Pharmaceutical Co., Ltd.

Overview

Qilu Pharmaceutical Co., Ltd. is a leading pharmaceutical company in China, engaged in the research, development, manufacturing, and marketing of both active pharmaceutical ingredients and finished dosage forms. The company is dedicated to providing high-quality, affordable medicines to patients across various therapeutic areas.

Therapeutic areas

API / Drug Master Files

Qilu Pharmaceutical Co., Ltd. holds 37 active (57 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.

• MARIBAVIRActive2025-06-27
• CARIPRAZINE HYDROCHLORIDEActive2025-03-14
• ARIPIPRAZOLE MONOHYDRATE (STERILE)Active2024-08-30
• ARIPIPRAZOLEActive2024-08-29
• NICARDIPINE HYDROCHLORIDE USPActive2023-09-28
• STERILE AVIBACTAM SODIUMActive2023-07-31
• CEFIXIMEActive2022-07-22
• PALIPERIDONE PALMITATE (STERILE)Active2021-12-31
• DIPYRIDAMOLEActive2020-08-06
• CEFPODOXIME PROXETILActive2020-02-17
• 3-(4-PHENOXYPHENYL)-1H-PYRAZOLO[3,4-D] PYRIMIDIN-4-AMINEActive2017-02-07
• CARFILZOMIB (NON-STERILE, API)Active2015-09-28
• DECITABINEActive2015-09-25
• SOLIFENACIN SUCCINATE (NON-STERILE, API)Active2015-06-15
• BORTEZOMIB (NON-STERILE, API)Active2015-05-06

Showing 15 of 57 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Qilu Pharmaceutical Co., Ltd. in our records. PharmaTek screens the full directory against live FDA enforcement data.