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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US FDA alert for import of one of the skin care product to Strides Acrolab

Strides Acrolab is a Bangalore Based pharmaceutical company.US FDA has put alert on one of the skin care product of the company which according to the company has approval to supply only in Africa and not in US. US FDA have already released a 483 and a warning letter to the company in the past and this is the second time when US FDA has again raised an issue.

The product is being manufactured by Strides Italian subsidiary; Beltapharm which is supplying to an African customer from almost past 5 years and is not having any clue of how any of these products have been distributed in the US territory.

According to the company it has only one Abbreviated New Drug Application approval for its Imiquimod cream for the US market which has been launched recently and is freely available.