PR No.131 Islamabad: 24th July 2018

DRAP has informed that recall process of batches of antihypertensive medicine Valsartan manufactured from the active pharmaceutical ingredient (API) supplied by M/s. Zheijiang Huahai Pharmaceuticals, China has near to completion at manufacturer’s level. The Pharmaceutical companies have submitted the data of their recalled batches which is under scrutiny by DRAP field offices. Some of the manufacturers have started production of their registered products containing valsartan after due procurement of API from alternate sources. Recently M/s. Searle Company, Lahore has informed that they are now manufacturing their product valsartan from an alternate source M/s. Zheijiang Tianyu Pharmaceuticals, China. API supplier firm has informed that they have randomly sampled three batches and studied. The results show that N-Nitrosodimethylamine (NNDMA) is not detected in their Valsartan ensures adequate safety and conforms to the regulatory requirement. M/s. Searle Company has been allowed to manufacture its registered products from the said source. Similarly M/s. Tabros and M/s. Pharm Evo have changed their sources of API Valsartan and have marketed their products. DRAP has already issued advisory for the healthcare professionals and patients that brands containing Valsartan from alternate sources can be prescribed and used by patients. Confusion regarding the usage of valsartan medicine is being clarified by DRAP that the Valsartan medicine or its manufacturers in Pakistan have never been banned but the products manufactured by API supplied by M/s. Zheijiang Huahai Pharmaceuticals, China was recalled after the precautionary recall alert issued by EMA. This precautionary recall was based on the detection of an unexpected impurity N-NDMA which is classified as probable carcinogenic. DRAP has issued instructions to manufacturers who are using API from alternate source to ensure the availability of their product in the market in best public interest and submit the compliance report.

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