News about Safety

Aarti Drugs to Halt Chlorosulfonation Process at Tarapur Unit After Gas Leak

The Maharashtra Pollution Control Board (MPCB) has directed Aarti Drugs to voluntarily close down chlorosulfonation process at the PTSCL section of its T-150 unit in Tarapur as a precautionary and safety measure, following a gas leakage incident.

Safety | 10/09/2025 | By Dineshwori

Dr Reddy's UK API Facility Receives Seven FDA Observations Following Inspection

Dr Reddy’s Laboratories has announced that its Active Pharmaceutical Ingredient (API) manufacturing facility in Mirfield, West Yorkshire, United Kingdom, has come under scrutiny from the United States Food and Drug Administration (FDA).

Safety | 08/09/2025 | By Darshana |  120

ASPA Calls for Unified, Multi-Stakeholder Approach to Combat Counterfeiting

Through evidence-based research, collaboration, and the adoption of authentication technologies, we can build a future where counterfeiting is no longer a silent threat, says Puneet Maithani, Director – Industry Affairs, ASPA.

Safety | 05/08/2025 | By Dineshwori |  155

Monitor NDMA Impurity in Ranitidine Formulation: DCGI Directs Indian Drugmakers

The DCGI has instructed drug controllers of all States and Union Territories to ensure that manufacturers under their jurisdiction monitor the presence of N-Nitrosodimethylamine(NDMA) - a potentially carcinogenic impurity – in the active pharmaceutical ingredient (API) and formulation of the antacid Ranitidine.

Safety | 31/07/2025 | By Dineshwori |  177

Sarepta Pauses Shipments of Duchenne Gene Therapy Elevidys Amid FDA Safety Review

Sarepta Therapeutics has announced a voluntary and temporary suspension of all US shipments of its Duchenne muscular dystrophy (DMD) gene therapy, ELEVIDYS (delandistrogene moxeparvovec), following the FDA’s distribution suspension request last week.

Safety | 24/07/2025 | By Dineshwori |  158

Custom Portable Sampling Isolator Improves Safety of Pharmaceutical Manufacturing

Custom Portable Sampling Isolator Improves Safety of Pharmaceutical Manufacturing

Safety | 18/08/2023 | By Sudeep Soparkar |  884

Lupin recalls 16,056 bottles of Rifampin capsules to treat TB

Manufacturing issues were cited

Safety | 23/01/2023 | By Sudeep Soparkar |  751

Laurus Labs' AP manufacturing block under fire

Four employees succumbs

Safety | 03/01/2023 | By Sudeep Soparkar |  1088

Freudenberg accomplishes ISO 14001 accreditation for its 11 overall destinations

Freudenberg Medical has accomplished ISO 14001 confirmation for every one of the 11 locales in the United States, Costa Rica, Germany, Ireland, and China. Meaning, all Freudenberg Medical activities overall satisfy the most noteworthy guidelines for ecological administration.

Safety | 13/04/2022 | By Sudeep Soparkar |  1083

Generic Pradaxa Capsules from Alembic Pharma given tentative approval by the US FDA

Alembic Pharmaceuticals Limited has gotten speculative endorsement from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for dabigatran etexilate cases, 75 mg, 110 mg, and 150 mg.

Safety | 08/04/2022 | By Sudeep Soparkar |  1022