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.
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.