Fabupharm operated without a licence for 17 months Hertta-Maria Amutenja Fabupharm Namibia (Pty) Ltd has been operating without a valid manufacturing licence for one year and five months.  From January 2024 up to June 2025, Fabupharm has been in violation of national pharmaceutical regulations. The Namibia Medicines Regulatory Council (NMRC) has now ordered the company to halt all pharmaceutical production. The NMRC said the company violated Regulation 35 of the Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003) by continuing to manufacture medicines without renewing its licence. Registrar of Medicines Fransina Nambahu issued a directive instructing Fabupharm to stop the production of pharmaceuticals and any other items requiring a valid manufacturing licence. “This instruction will remain in force until Fabupharm is compliant,” she said. The Council said the order applies to all product lines and follows an earlier instruction that targeted only Fabupharm’s oral liquid dosage block.  That previous inspection led to a recall of oral liquid medicines and a temporary halt to that specific line. No timeline has been given for when production might resume.  The Council’s latest move follows increased scrutiny of the company’s operations. Last month, Fabupharm’s children’s paracetamol syrup faced public criticism after concerns were raised about its safety. This resulted in the council halting its production.  The NMRC did not refer to the syrup in its current statement but confirmed that broader manufacturing practices at the company are under review. The ministry of health and social services also recently recalled Fabupharm’s chlorhexidine 4% solution after receiving complaints.  That recall is not linked to the licence issue but has added to concerns about quality control. Fabupharm, based in Otjiwarongo, has stated that it operates under Good Manufacturing Practice (GMP) standards.  The company said its quality management system is validated, and its products are tested independently by the Government Quality Surveillance Laboratory under the health ministry. Fabupharm, which has been in operation since 1989, produces more than 300 pharmaceutical products for public and private sector use.  In 2023, the company was involved in a contested medical tender process with the Central Procurement Board. Efforts to obtain comments from Fabupharm were unsuccessful at the time of publication.

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Second recall in six months hits Fabupharm Justicia Shipena A routine inspection conducted on Monday uncovered several shortcomings in Fabupharm Namibia (Pty) Ltd’s oral liquid dosage block, the Namibia Medicines Regulatory Council (NMRC) has said. As a result, the NMRC instructed the company to recall all its oral liquid products and halt production on the affected liquid line until the issues are corrected. “The inspection of the oral liquid dosage block observed shortcomings which necessitated various corrective and preventative actions,” said Fransina Nambahu, registrar of the NMRC. The directive follows pressure from member of parliament Job Amupanda, who last week urged the council to act after claiming he had evidence that Fabupharm’s children’s paracetamol syrup was unsafe. Nambahu said production may only resume once the highlighted issues are fully addressed in line with standard manufacturing requirements. She said the NMRC is committed to ensuring access to safe, effective, and quality-assured medicines for all Namibians. “Further information regarding the Council’s fulfilment of this mandate in this regard will be provided in due course.” Fabupharm last week maintained that its children’s paracetamol syrup is safe. The Otjiwarongo-based company had stated it had not received any formal communication from the Council indicating that its product was defective, unsafe, or non-compliant with regulations. At that time, the company maintained that its paracetamol syrup is manufactured according to strict international Good Manufacturing Practice (GMP) standards and follows guidelines from the World Health Organisation (WHO) and local regulatory frameworks. Amupanda on Wednesday welcomed the Council’s decision. “I welcome the implementation of my instructions to the Minister and the Namibia Medicine Regulatory Council (NMRC) with regard to the products of Fabupharm as taken on Monday, 02 June 2025, as soon as the Minister returns to the country,” he said. He said no one should play with the health of people, especially children. This is not the first time Fabupharm has been ordered to recall a product. In January, the Ministry of Health and Social Services recalled a facial scrub due to quality concerns.  The scrub, chlorhexidine 4% 20L, was manufactured by Fabupharm in Otjiwarongo. According to a letter from the ministry’s deputy director of operations, Barnabas Iitula, dated 16 January, the recall followed multiple complaints from end-users.

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Fabupharm told to recall oral liquid medicine after council discovers manufacturing issues The Namibian Medicines Regulatory Council (NMRC) has instructed Fabupharm to recall its oral liquid products over manufacturing standard concerns. NMRC registrar Fransina Nambahu says instructions were issued to Fabupharm Namibia to initiate a recall of all oral liquid products and to stop manufacturing the affected liquid line until certain matters were corrected. “A routine inspection of its manufacturing facility was carried out to validate the status of goods manufacturing practices.” Nambahu says the inspection of the oral liquid dosage block observed shortcomings which necessitated various corrective and preventive actions. “The NMRC is committed to carry out its mandate by ensuring access to safe, effective and quality assured medicines to the Namibian people,” she says. The post Fabupharm told to recall oral liquid medicine after council discovers manufacturing issues appeared first on The Namibian.

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Fabupharm ordered to recall oral liquid medicines Fabupharm ordered to recall oral liquid medicines NBC Online Wed, 06/04/2025 - 13:36

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Fabupharm dismisses claims of unsafe paracetamol syrup Fabupharm has dismissed claims circulating on social media suggesting that its paracetamol syrup may be unsafe or of poor quality. This follows allegations by Affirmative Repositioning leader and member of parliament Job Amupanda, who alleges that the syrup used to treat fever and pain in children is defective. Fabupharm is a 100% Namibian-owned producer and the only fully-fledged pharmaceutical manufacturing entity in Namibia. The company’s managing director, Francois Slabbert, in a statement yesterday said the product meets all regulatory standards and remains safe for public use. “We would like to categorically state that Fabupharm has not received any formal communication or notification from the Namibia Medicines Regulatory Council (NMRC) indicating that Fabupharm Paracetamol Syrup is defective, unsafe, or not compliant with regulatory standards,” he said. Slabbert said the Fabupharm syrup is produced under strict international good manufacturing practice standards, as set by the World Health Organisation and local regulations. According to him, the company runs a validated quality management system that tests raw materials, production processes, and finished products. “All our products are routinely and independently tested by the Government Quality Surveillance Laboratory under the Ministry of Health and Social Services. This external oversight provides an additional layer of assurance that our medicines meet the highest standards of safety, efficacy and consistency. To date, there have been no product recalls, regulatory warnings, or confirmed quality failures relating to our paracetamol syrup,” he said. Slabbert urged the public to stop spreading false information, saying this causes unnecessary concern among families who depend on the medicine. The company said it has in the past invited stakeholders including politicians to visit its Otjiwarongo facilities and former finance minister Iipumbu Shiimi has even paid them a visit. Amupanda claims the medicine council inspected the facility and discovered that the syrup does not meet standards and has been classified as having critical defects in terms of their report. “I have discovered, I have concrete information and evidence of the effect of the Fabupharm paracetamol syrup, meant to ease pain and fever for children”. Amupanda describes it as a life-threatening syrup, which has been allowed to be distributed for two years. “Of course, the children of the poor who are treated at public hospitals are affected and they can’t afford private facilities where they can get proper medication. . . Some people are speculating that they might be in the pockets of Fabupharm,” he says. Amupanda questions why the council had this information for two years but nothing was done about it. Attempts to contact NMRC proved futile at the time of publication. The post Fabupharm dismisses claims of unsafe paracetamol syrup appeared first on The Namibian.

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