The product will be manufactured at a USFDA approved contract manufacturing organisation
This has led to rise in warnings too; 55% of GMP warnings since 2012 issued to Indian, Chinese cos
Warning letters might increase as 190 facilities are expected to be inspected in the next 3 years
The FDA Form 483 notifies the company's management of objectionable conditions
Violations include failure to have adequate cleaning procedures to prevent contamination of products
A bill that would speed up approval for medications and medical devices shows how a major initiative can get traction
Drug controller is rest assured that only recommendations will be taken and the will ensure that laws do not harm the medium and small players in India
USFDA released a copy of EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when agency determines the inspection to be closed
Orchid Pharma stock was trading up 12.18% at Rs 41.90 during the afternoon trade on BSE
The federal agency had taken action against companies like Sun Pharma last year & earlier Ranbaxy among other Indian drug companies.