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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Guilin Pharma’s first WHO certified API: Artemether

Guilin Pharma has announced its first World Health Organization (WHO) product quality (PQ) certification for the anti-malarial drug Artemether. The drug has been included in the WHO’s PQ certified list for global buyers.

Artemether is an anti-malarial drug used for the treatment of multi-drug resistant strains of Plasmodium falciparum. It is now included in the WHO list of essential medicines, a baseline list of important drugs required in a basic healthcare system.

Guilin Pharma is a member of the Fosun Pharmaceutical group, and has been applying for the API-specific PQ certification since its initiation in October 2010. The Artemether API product line API-II passed the WHO good manufacturing practices (GMP) inspection in July 2012 and received the acceptance number. This approval marks Guilin Pharma’s first API-specific PQ certification by WHO, setting the stage for more of Guilin Pharma’s APIs to go global.