The US Food and Drug Administration (USFDA) has given its approval for Ipca Laboratories’ oral solid dosage formulations manufacturing facility situated at Madhya Pradesh after an inspection.
Post the approval, the company said that it would be able to commercialise oral solid dosage formulations in the US market from the formulations manufacturing facility situated at Pharmazone, SEZ Indore, Pithampur, Madhya Pradesh.
In fact, the company had got the USFDA approval for its Indore facility in July 20, 2012 itself.
The company said that during the course of an internal quality assurance review, it had noticed a few non-conformances at the unit. So, it had voluntarily referred the same to the USFDA, and the same was under discussion with it for an appropriate resolution.
The facility has now been cleared once again, it added.