The shares of Natco Pharma tumbled 2.3% to their day’s low of Rs 844.25 on the BSE, while those of Shilpa Medicare slid 1.5% to Rs 345.40. Meanwhile, Lupin shares fell as much as 1.6% to a low of Rs 1,996.15 and the shares of Alkem Laboratories slipped 1% to Rs 5,639.50.
Lupin
The USFDA completed an inspection of Lupin’s Goa unit between November 10 and 21, issuing a Form 483 with seven observations. The company said it will submit its response within the prescribed timeline and remains committed to maintaining CGMP compliance across all facilities.Lupin’s stock has risen 5% over the past month but is still down 14% in 2025.
Shilpa Medicare
Shilpa Medicare’s Unit IV in Jadcherla underwent a 10-day USFDA inspection that ended on November 21. The regulator issued a Form 483 with eight observations—none marked as repeat issues.The facility handles manufacturing, packaging, testing, storage and distribution of sterile injectables, oral tablets and capsules for the US, Europe and other global markets.
Natco Pharma
The USFDA also inspected Natco Pharma’s API plant in Chennai from November 17 to 21, issuing a Form 483 with seven observations at the close of the audit.
Natco said in its exchange filing that the points raised are procedural and will be addressed fully, adding that the company remains committed to CGMP standards and global supply of high-quality products.
Shares of Natco are up 4.5% in the past month but have slumped 40% so far in 2025.
Alkem Laboratories
Separately, a GMP audit by the Ministry of Health, Armenia, at Alkem’s Sikkim facility—conducted between November 21 and 22—concluded without any critical or major observations, the company said in a filing.
