Pharma majors reactive of USFDA inspections
Bhagyashree Vivarekar / 17 Apr 2017
Pharma companies went through USFDA inspections where Dr Reddy witnessed no observation while Sun Pharma and Unichem Lab received observations at their major exporting plants.
Dr. Reddy’s Laboratories surged as much as 2.2% at Rs 2700 after USFDA completed inspection at its API Srikakulam Plant without any observations. Srikakulam plant contributes nearly 9-10% to revenue from US together with Duvvada.
Earlier USFDA had inspected 3 plants that included 2 API plants at Srikakulam and Miryalguda and one formulations at Duvvada, and subsequently had issued warnings. Srikakulam facility witnessed existence of an uncontrolled Custom QC laboratory which was not disclosed to USFDA. This had delayed launches of major products Esomeprazole and Capecitabine.
On the contrary, Sun Pharma’s formulation plant at Dadra is said to have received 11 observations by USFDA. The stock tumbled as much as 2.1% at Rs 678, dragging entire pharma sector to fall marginally by 0.4%. Dadra plant is said to be the second major facility after Halol plant that contributes to US revenue.
Moreover, Unichem Lab is also said to have received 483 observation at its Goa plant amid lacking full-fledged records. Goa stands as one of the US revenue generating plants of Unichem. However, the stock recovered from day’s low of 272 and surged 2.4% at Rs 292.5 after receiving ANDA approval for its Piroxicam Capsules USP 10mg & 20mg, used for relief from the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA).