Drug firm Shilpa Medicare Ltd announced that the United States Food and Drug Administration (USFDA) has closed the inspection at its Analytical Services Division in Hyderabad with two minor observations pertaining to improvements in existing procedures.
The company’s Analytical Services Division situated at Nacharam, Hyderabad, Telangana was inspected by US drug regulator from March 8 to March 10, the company said in filing to the stock exchanges.
"The inspection is closed with two minor observations, which are related to improvements in existing procedures and are addressable," the company said.
The Karnataka-based drug firm said it will submit the responses to USFDA observations within the stipulated timeline and will work towards implementing the corrective actions to address the observations.
This is the second USFDA inspection on the site. The initial inspection was done during April 2022, for which the GMP clearance (EIR) was issued in July 2022.
The facility is engaged in analytical testing of drug products, drug substances, raw materials and packing materials. It is also involved in analytical method validations, method transfers and conduct of other miscellaneous studies. Also, it is engaged in the testing of US, EU and other markets commercial batches.
In December 2022, the drug firm had launched capecitabine dispersible tablets to treat breast cancer. The capecitabine dispersible (Capebel) 1,000 mg tablet was introduced with the technology of faster dispersion within 90 seconds to treat colorectal and metastatic breast cancer.
Shares of Shilpa Medicare ended 3.8 percent lower at Rs 258.
