Cipla Challenges FDA's License Cancellation in Maharashtra
Cipla contests the Maharashtra FDA's order over alleged irregularities at its Pune unit, emphasizing product safety.
Cipla contests FDA's order on Pune unit
License canceled due to packaging irregularities
No safety concerns for products raised by FDA
Cipla has formally contested an order from the Maharashtra Food and Drug Administration (FDA) that canceled the drug sale license for its Pune unit due to alleged irregularities in storage, packaging, and recall procedures. The company stated that the matter is currently sub judice and refrained from further comments as it is under judicial consideration.
The FDA's decision, effective from August 27, 2026, pertains to the operations of a carry and forwarding (C&F) warehouse linked to Cipla. The regulator noted that this was the second instance of concern, with previous issues raised in March 2026 regarding the labeling of Reactin Plus Tablets, which was deemed unauthorized. The FDA has ordered a recall of the misbranded medicine, citing potential public health risks associated with self-medication.
