JAKARTA - PT Pharos Indonesia, as the manufacturer of Praxion fever-reducing syrup, stated that its product meets the requirements set out in the Indonesian Pharmacopoeia VI supplement II based on the results of a product safety retest conducted by an independent laboratory.
The Praxion syrup drug is suspected to be the cause of the emergence of new cases of atypical progressive acute kidney disorder (GGAPA) in which the kidneys stop working suddenly.
"It meets the requirements for the Indonesian Pharmacopoeia VI supplement II based on the results of a re-test on the safety of Praxion syrup products conducted by an accredited independent laboratory," said PT Pharos Indonesia's Director of Corporate Communications Ida Nurtika in a written statement, Wednesday 8 February, as reported by Antara.
Indonesian Pharmacopoeia Edition VI includes standards that must be met in the production of drugs and medicinal raw materials. Indonesian Pharmacopoeia Edition VI contains general provisions; list of monographs of general preparations, medicinal substance monographs, and drugs; as well as an explanation of the analytical methods and testing procedures contained in the monograph.
Ida said that testing of Praxion syrup samples was carried out by three laboratories, including the Saraswanti Indo Genetech Laboratory and the Sucofindo Laboratory.
"The results (examination) from the two labs show that Praxion products meet the specifications for the Indonesian Pharmacopoeia VI supplement II or meet the requirements," she said.
According to her, the results of testing samples of Praxion syrup from the two laboratories had been submitted to the Food and Drug Supervisory Agency (BPOM) and the results of tests carried out by the third laboratory would be submitted after the process was complete.
The Praxion syrup drug is suspected to be the cause of the emergence of new cases of GGAPA or acute kidney disease in the country. According to the Ministry of Health, children with kidney problems in January 2023 consumed Praxion fever-reducing syrup purchased from pharmacies.
PT Pharos Indonesia has voluntarily withdrawn the Praxion drug product in the related batch. All of the company's distribution and sales partners were also asked not to sell the drug product for the time being.
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In addition, the company re-tests product safety in internal laboratories and independent laboratories in accordance with the provisions in the Indonesian Pharmacopoeia edition VI, supplement II.
Ida said that the results of the internal inspection showed that the Praxion syrup product complied with the specifications in the Indonesian Pharmacopoeia.
"PT Pharos Indonesia will continue to be cooperative with BPOM and the Ministry of Health, and wait for directions regarding further steps that need to be taken," said Ida.
Meanwhile, BPOM verifies the results of testing of medicinal raw materials carried out by the pharmaceutical industry to check fulfillment of requirements such as supplier qualifications, testing of raw materials for each arrival and each container, as well as testing methods based on the latest standards or pharmacopeias.
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