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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Successful Completion of USFDA inspection by Shasun Pharmaceuticals Ltd

Manufacturing facility of Shasun Pharmaceuticals based at Dudley,England has successfully completed US FDA inspection.The inspection was held in the first week of November 2014.

Shasun is a leading manufacturer of APIs and formulations catering to the needs of customers globally. Shasun offers formulation and and generic manufacturing services at its Indian sites. Shasun also offers contract research and manufacturing services for APIs in India and UK.

The USFDA concluded that the facility, systems and practices comply with the requirements laid down by US FDA and thus have given no observations on the form 483.