Wockhardt shares rallied nearly 5 percent intraday Tuesday after the US health regulator excluded an antibiotic drug from the import alert.
“US Food and Drug Administration (USFDA), on September 30, excluded the product Ceftriaxone sodium from import alert,” the Mumbai-based pharmaceutical and biotechnology major said in its filing.
This will enable the company to manufacture and sell Ceftriaxone API and formulation to US market.
It manufactures this antibiotic drug from its API unit at Ankleshwar, Gujarat. The unit had received an import alert 66-40 from the USFDA for this facility in August, which is still continued.
Sources told CNBC-TV18 that the reason for exclusion of this drug from import alert is due to shortage in the US market.
Ceftriaxone Sodium, the generic version of Hoffman La Roche’s Rocephin injection, was approved by USFDA in May 2006.
Meanwhile, Wockhardt has received 11 observations from USFDA for US facility Morton Grove that contributed 35-40 percent to US sales, reports CNBC-TV18 quoting unnamed sources.
The facility was inspected by the US health regulator in February 2016.
CNBC-TV18 learned that following are USFDA observations received for Morton Grove facility:
->Quality control unit lacks authority & responsibility to reject all drug products
->There is a failure to thoroughly review any unexplained discrepancy
->Control procedures have not established to validate manufacturing process performance
->Records have not made of investigations into unexplained discrepancies
->In-process materials have not tested for identity, strength, quality & purity
->Written procedures have not followed for sampling, testing of components
->Rejected components have not controlled under quarantine system
->Components & containers have not withheld until quality control unit’s clearance
->Records are not maintained so that data can be reviewed at least annually
->Routine calibration, inspection have not performed as per programme
->Appropriate controls have not exercised over computers or related systems
At 11:02 hours IST, the scrip of Wockhardt was quoting at Rs 914.35, up Rs 19.90, or 2.22 percent on the BSE.
Posted by Sunil Shankar Matkar