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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Health Canada backtracking regulatory actions on Apotex Banned Drugs

Health Canada is reconsidering its actions taken to ban all the products manufactured at Apotex and IPCA laboratories in India. Almost 30 finished products and API's of Apotex Plant at Bangalore and 20 API's and 50 products of IPCA Laboratories at Ratlam were banned for import in Canada.

Health Canada will now allow the drugs and API's to be imported into the country as they are medically necessary. These products include the beta blocker atenolol from Actavis and Teva and the heart drug losartan from Teva as well as the attention deficit hyperactivity disorder (ADHD) drug methylphenidate from Apotex. The products will be allowed to be imported only after it is tested by independent third party for compliance with the regulations of Health Canada and thereby ensuring the health and safety of the Canadians.