Statin APIs from Gedeon Richter-linked firm should be prohibited say GMP inspectors

By Gareth Macdonald contact

- Last updated on GMT

iStock/ollaweila
iStock/ollaweila

Related tags: Active ingredient, Simvastatin

German regulators want statin APIs made by Artemis Biotech to be banned after finding deviations good manufacturing practice (GMP) at the firm’s facility in Hyderabad, India.

The recommendation was made in a report​ filed on the EurdaGMDP database last week, which detailed problems identified at Artemis’ plant in Jeedimetla in June.

The inspectors from the Schleswig Holstein state government stopped short of ordering a recall but did say the plant – which produces statin active pharmaceutical ingredients (API) – should not be allowed to supply ingredients for drugs sold in Europe. They also advised national authorities to assess the situation.

Each involved NCA should evaluate, following assessment conducted in conjunction with MAHs, if a potential recall of medicinal product is needed. The risk based evaluation should take in account if there are alternative suppliers and potential risk of shortage.”

It added that: “Given the nature of non-compliances, assessment should include a complete retest of all imported batches of active substance​.”

The inspectors raised questions about the site's quality management system, the lack of documentation of repackaging activities, failure to label raw materials and APIs. They also said the company’s approach to the validation of computer systems is non-compliant.

Statins

Artemis is a division of Themis Medicare – a joint venture between the firm’s Indian founders and Hungarian drug manufacturer Gedeon Richter. It makes simvastatin using lovastatin as a starting material.

The firm has several CEPs from the EDQM, for Simvastatin Butylated Hydroxy Anisole 50 - 150 ppm R1-CEP 2006-091-Rev 00; Simvastatin Butylated hydroxy anisole 0.18-0.22% R1-CEP 2007-155-Rev 01; Simvastatin Antioxidant Butylated Hydroxy Toluene 0.01% R1-CEP 2003-257-Rev 03.

The German regulators have asked the EDQM to review the CEPs.

Artemis also makes the antibiotic Fumagillin for the French market. However, according to the German regulators, “this API was not within the scope of this inspection​.”

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