Strides Arcolab announced Friday that its oral dosage manufacturing site in Bangalore, India, was recently approved by the US FDA following a GMP compliance audit.
The last FDA inspection and approval of the facility -- which manufactures oral dosage forms such as tablets, capsules and sachet -- was in 2011. Strides has four other facilities with which it provides treatments for more than 75 countries.
The approval comes as Strides is still dealing with a Form 483 the company received from the FDA back in August for its injectables facility.
That letter cited the company’s insufficient response to corrective actions, as well as its failure to establish an appropriate monitoring system of environmental conditions.