Getz Pharma’s Valsartan brands were marked “Safe For Use” in an alert issued by the Provincial Drug Control Unit (PDCU), Government of Punjab on 18th July, 2018.
According to the PDCU alert, only a few companies’ Valsartan brands were void of carcinogenic impurities that were initially found in Valsartan sourced from a Chinese company, Zhejiang Huahai. The Drug Regulatory Authority of Pakistan (DRAP) also issued a statement the same day that, clearing that Valsartan has been recalled, not been banned. It added that the brands not sourcing their Valsartan from Zhejiang Huahai are safe for the use of patients.
The alert came after the European Medicines Agency (EMA) found carcinogenic impurities in Valsartan raw material manufactured and supplied by Zhejiang Huahai. This called for a worldwide recall on 5th July, 2018 of the brands that used that company’s Active Pharmaceutical Ingredient (API). On 12th July, 2018, DRAP also found impurities in some companies’ Valsartan brands and issued a recall. Similarly, the Provincial Drug Control Unit (PDCU), government of Punjab, also confirmed the impurity, and issued a recall of those batches.
Getz Pharma’s Valsartan brands, Cova, Cova-H and Covam, being made at the only manufacturing facility in Pakistan that is Pre-qualified and Approved by the World Health Organization (WHO) Geneva and a member country of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), were declared “Safe For Use” because Getz Pharma has the Technology and Quality Management Systems, approved by WHO and PIC/S, to evaluate and qualify APIs.
So if you are using Valsartan, there is no red flag. You can still take Valsartan. Just consult your Doctor or Pharmacist to recommend you Valsartan brands which are safe for use.
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