Indonesia revokes licenses of syrup-type drug production of 2 local firms over violation of manufacturing rules
BPOM chief Penny K. Lukito told reporters that the "oral liquid" manufacturing licences of the two companies, PT Yarindo Farmatama and PT Universal Pharmaceutical Industries, have been revoked, adding that BPOM is pursuing criminal action against them.;
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Jakarta: Indonesia's food and drug agency (BPOM) said on Monday it had revoked licenses of syrup-type drug production of two local firms for violating manufacturing rules, as it probes the deaths of more than 150 children due to acute kidney injury (AKI).
The decision comes after Indonesia temporarily banned sales of some syrup-based medications and identified the presence in some products of ethylene glycol and diethylene glycol as possible factors in AKI deaths, most of which were of children under five.
The two are used in antifreeze and brake fluids and other industrial applications but also as a cheaper alternative in some pharmaceutical products to glycerine, a solvent or thickening agent in many cough syrups. They can be toxic and lead to acute kidney injury.
BPOM chief Penny K. Lukito told reporters that the "oral liquid" manufacturing licences of the two companies, PT Yarindo Farmatama and PT Universal Pharmaceutical Industries, have been revoked, adding that BPOM is pursuing criminal action against them.
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