Dr. Reddy's Laboratories Ltd.
Overview
Dr. Reddy's Laboratories Ltd. is a global pharmaceutical company based in India, engaged in providing affordable and innovative medicines. The company offers a wide portfolio of products and services, including pharmaceutical generics, active pharmaceutical ingredients, biosimilars, and differentiated formulations.
Therapeutic areas
API / Drug Master Files
Dr. Reddy's Laboratories Ltd. holds 279 active (368 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.
- ALECTINIB HYDROCHLORIDEActive2026-03-31
- ADAGRASIBActive2026-03-31
- TAFAMIDISActive2026-03-31
- FINASTERIDE - USP (FORM-I)Active2026-03-31
- TIRZEPATIDEActive2026-03-31
- PIRTOBRUTINIBActive2026-03-31
- PENTOSAN POLYSULFATE SODIUMActive2026-03-31
- PERFLUOROHEXYLOCTANEActive2026-03-30
- DAPAGLIFLOZIN PROPANEDIOL (DPD-1)Active2026-03-30
- EMPAGLIFLOZIN (EFG)Active2026-03-20
- DEUCRAVACITINIB PREMIXActive2026-02-27
- RIVAROXABAN USP [PROCESS-II]Active2025-12-31
- ATORVASTATIN CALCIUM TRIHYDRATE [FORM-I] USP [AFP PROCESS]Active2025-12-30
- NILOTINIB PREMIX (HPMC AS)Active2025-12-30
- TUCATINIB COPOVIDONE ASDActive2025-08-19
Showing 15 of 368 Drug Master Files.
FDA compliance signals
50 FDA enforcement records linked to this company.
- recall — Class III2025-12-17
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
- recall — Class II2025-10-15
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
- recall — Class II2025-07-23
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
- recall — Class I2025-04-23
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
- recall — Class III2024-12-18
Failed Impurities/Degradation Specifications
- recall — Class III2024-11-27
Failed Tablet/Capsule Specifications
- recall — Class II2024-11-13
Failed Impurities/Degradation Specification
- recall — Class II2024-11-13
Failed Impurities/Degradation Specification
- recall — Class II2024-11-06
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- recall — Class II2024-11-06
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- recall — Class II2024-11-06
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- recall — Class II2024-09-04
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- recall — Class II2024-09-04
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- recall — Class II2024-09-04
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- recall — Class III2024-08-14
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
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