Indian authorities have suspended the manufacture of a Wockhardt fixed dose combination drug, the company has announced in a filing.
The announcement on the Bombay Stock exchange yesterday stated the State Drug Controller of the Himachal Pradesh region of India “has suspended the manufacture, sale or distribution of Fixed Dose Combination (FDC) Dicyclomine Hydrochloride IP 10mg, Tramadol Hydrochloride IP 50mg & Acetamenophen IP 325mg.”
No reason was given and in-Pharmatechnologist.com attempted by phone and email to contact Wockhardt and the State Drug Controller, but did not get a response by the time of going to press.
However, the filing said “The Company in order to revoke the said suspension is filing an appeal before the State Government under the provisions of applicable law,” and stated the product contributed less than 3% of the Consolidated Sales of Wockhardt last year.
We also contacted the State Drug Controller, Navneet Marwah, for more information behind the decision but he was unable to respond to our enquiry at the time of going to press. However, he told Reuters , the Indian regulators acted on complaints from consumers.
According to the firm’s website, Wockhardt has one manufacturing facility in the Himachal Pradesh but this is not one of the two facilities that have been subjected to sanctions from foreign regulators in the past year.
Both the US Food and Drug Administration (FDA) and the UK’s MHRA have come down hard on the firm’s Waluj oral solid dose facility and its generics and antibiotics Chikalthana facility, both of which are in Aurangabad, Maharashtra, after discovering manufacturing quality issues.
The firm’s share price reached a six month high yesterday, but dipped slightly following the announcement.