Ahmedabad-based Torrent Pharmaceuticals said its manufacturing facility at Indrad in Gujarat was subject to certain ‘procedural observations’ by the United States Food and Drug Administration following a routine inspection.
The pharma company did not quantify how many observations were made by the US health regulator.
Procedural observations are referred to as deficiencies in standard operating procedures in production, testing and hygiene. They are considered relatively easy to address than critical and mildly critical observations.
Indrad is Torrent’s most important manufacturing facility, supplying to the US market. Torrent derives 30% of its revenue from the US market.
Torrent said that it is ready to address the USFDA observations satisfactorily.
The regulatory agency had carried out an inspection at the Indrad facility in May 2017, following which it issued four observations relating to improvement in procedures and in documentation processes.
Torrent pharma also manufactures insulin tablets for Danish pharma firm Novo Nordisk at Indrad.
The latest audit comes a month after the USFDA inspections at Torrent’s manufacturing facility in Dahej, Gujarat. It too received procedural observations during the routine audit.
Torrent Pharmaceuticals Ltd, the flagship company of the Torrent Group, operates in more than 50 countries with over 1000 product registrations globally.
Torrent Pharma is active in the therapeutic areas of Cardiovascular (CV), central nervous system (CNS), gastro-intestinal, diabetology, anti-infective and pain management segments. The company has manufacturing facilities in Gujarat, Sikkim, Himachal Pradesh, Madhya Pradesh and Andhra Pradesh.