IGMPI India

October 7, 2015

October 7, 2015

PAN Drugs receives warning letter from USFDA

USFDA has recently issued a warning letter to PAN drugs Vadodara based plant due to significant deviations from good manufacturing practices.

MHRA issues recall notice of Lacri-Lube eye ointment

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a recall notice to Allergen Limited. The recall notice relates to 5g and 3.5g pack sizes of

Another Import Ban for Polydrug Laboratories

USFDA (Food and Drug Administration) issues import ban for products manufactured by Polydrug Laboratories. It was issued on Sept. 11, 2015 for

Health Canada lifts its ban from two Apotex facilities in India

Health Canada has lifted its ban from Apotex two Indian facilities. Canada’s drug regulator reinspected the two plants in June and determined

33 drugs were found to be of not of standard quality during Surprise inspection

Recently Karnataka drug control department had conducted surprise inspections to pick up drug samples at random. The drug test labs have issued their result.

Vivimed Labs successfully completes USFDA inspection of its manufacturing facility

Vivimed Labs has recently successfully completed inspection of its API manufacturing facility in Spain. After the completion of inspection Vivimed said “the USFDA inspectors concluded

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Sun Pharma units product in present form disapproved by FDA

According to the announcement made by Sun Pharma Advanced Research Company (SPARC), their New Drug Application (NDA), for a product of the anti-depressant variety in the present form has been disapproved by USFDA.

It also stated that the USFDA has issued a letter that demands additional studies that detail about the safety and efficacy of the product. The product in discussion is Venlafaxine 300 mg tablets with extended release. The company, SPARC has received a complete response letter, which is a communication that the USFDA provides when a new drug application cannot be approved in the present form.

The company aims at working in this direction and according to the USFDAs remarks and feedback, the company would be evaluating whether the product can be commercial viable. The necessary actions would be taken and the company aims at providing the communication demanded by the FDA.