IGMPI India

October 7, 2015

PAN Drugs receives warning letter from USFDA

MHRA issues recall notice of Lacri-Lube eye ointment

Another Import Ban for Polydrug Laboratories

Health Canada lifts its ban from two Apotex facilities in India

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

Vivimed Labs successfully completes USFDA inspection of its manufacturing facility

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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Three batches of Transplant medicine recalled from PHL market

A pharmaceutical company has recalled three batches of thymoglobuline (rabbit-derived antibodies to treat rejection of transplanted organs) from the Philippine market. The drug being recalled is used in the treatment of severe aplastic anemia and organ transplants. Rabbit Anti-Human Thymocyte Immunoglobulin as a biological product indicated for immunosuppression in transplantation or prophylaxis and treatment of graft rejection.

The Food and Drug Administration (FDA) said Sanofi-Aventis Philippines Inc. has initiated a voluntary recall of three batches of Rabbit Anti-Human Thymocyte Immunoglobulin, or Thymoglobuline. The company has recalled batch C1272H08 with expiry date of March 2014 and batch C1282H20 and C1282H31, with expiry dates of May 2014.

FDA said that due to out of specification (OOS) findings on the product stability prior to the expiration date, specific batches of Rabbit Anti-Human Thymocyte Immunoglobulin (Thymoglobuline) 5mg/ml Powder for Solution for IV Infusion has been voluntarily recalled. According to FDA the recalled batches were manufactured in France.