EMA bans APIs from two Indian manufacturers

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Italian regulators recently inspected a couple of Indian API makers and came away with concerns. Now the European Medicines Agency has called for recalls of all of their products and banned them from future shipments.

The actions were taken against a JP Laboratories unit in Maharashtra and a Krebs Biochemicals & Industries plant in Andhra Pradesh following inspections in March. 

In the case of API maker JP Laboratories, inspectors documented 28 deficiencies, 9 of them major. Those involved quality management and data integrity, as well as materials management, equipment validation and others. The problems were so pervasive that regulators said, “The extent and severity of the findings, in combination with the repeated negative inspection outcome, demonstrates the inability of the company to sustain an acceptable GMP compliance level, and constitutes a critical risk for public health.”

The EMA pulled the plant’s certificate of suitability and the agency recommended that all of JP Laboratories' products be recalled, unless countries determine it would lead to shortages of specific meds in their areas.

With simvastatin API maker Krebs, inspectors documented 24 deficiencies, 5 of which were considered major. The regulator said weaknesses in quality management at the plant “demonstrated a critical risk to public health.” The major deficiencies were in several areas including deviation management and the plant’s monitoring of purified water.  

The EMA also pulled the certificate of suitability for Krebs and suggested that countries recall its products as well.  

Like the U.S., Europe gets much of its API production from India and so monitors the industry there closely. The EMA has taken actions against half a dozen Indian manufacturers since the first of the year but has also taken steps against plants in China, Spain, France and even in the U.S. Last week, at the suggestion of inspectors from Sweden, the agency banned products from Capsugel’s Bend Research facility in Oregon over what it termed “Repeated failures to correct deficiencies and to provide requested and reliable information.”

- access the reports here 

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