Drug firm Vivimed Labs has said the US health regulator's inspection of its API manufacturing facility in Spain has had a favourable outcome.
The company's "API manufacturing facility located at Llica de Vall, Spain, has had a favourable outcome, post its US Food and Drug Administration (USFDA) inspection," Vivimed Labs said in filing to BSE.
The audit was conducted during the second week of September, which concluded on September 18, 2015, it added.
"On completion of the inspection, the USFDA inspectors concluded that the facility, its systems and practices comply with USFDA requirements with no observations reported on Form 483," Vivimed said.
Form 483 is issued to a firm management at the conclusion of an inspection when an investigator observes any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act.
Vivimed Labs MD and CEO Santosh Varalwar said: "This is in line with the group's constant focus on maintaining high levels of regulatory compliance, which is a key differentiator in today's regulatory landscape, in the global generics pharmaceutical market."
Vivimed has had a satisfactory outcome on the regulatory compliance front with all four of its USFDA-approved manufacturing plants during the last one year, the company said.
The stock was trading at Rs 293.60 in the afternoon trade on BSE, up 1.63 per cent.
