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.
