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NAFDAC blacklists Indian drug manufacturer, Mars Remedies over falsification

NAFDAC blacklists Indian drug manufacturer, Mars Remedies over falsification

NAFDAC blacklists Indian drug manufacturer, Mars Remedies over falsification.

All manufactured products by Mars Remedies PVT Limited, India is banned by the National Agency for Food and Drug Administration and Control (NAFDAC) on weekend for the falsification of Ciprofloxacin Tablets BP 500 mg with NAFDAC registration number NO C4-0498 for Pinnacle Health Pharmaceutical Ltd.

In a press statement authorized by Director-General Prof. Moji Christianah Adeyeye, the Agency ruled that all goods manufactured by Mars Remedies PVT LTD, 635, GIDC Estate Waghodia, Vadodara, Gujarat , India, will no longer be permitted to enter Nigeria with immediate effect, in view of unprofessional practice.

In a letter dated October 9, 2020, forwarded to the Managing Director of Mars Remedies PVT Limited, entitled, “Notice of blacklisting as a manufacturer of substandard and falsified medicines,” Adeyeye claimed that the agency has zero tolerance in Nigeria for the preponderance of substandard and falsified medicines.

“In breach of existing NAFDAC laws and regulations, the company illegally developed various formulations of Ciprofloxacin tablets for export to Nigeria rather than the authorised formulations.”

The difference in the formulation of the Ciprofloxacin 500 mg tablets, which may affect the quality of the product and shelf-life, was not licensed by the Agency before the changes were made, according to Adeyeye.

This is a breach of the NAFDAC Act, noting with dismay that the corporation has shown a blatant negligence for compliance with global standards required to ensure the manufacture of quality-assured goods. The business has since been correspondingly blacklisted.

She cautioned all producers and importers of medicinal products to conform explicitly to the conditions under which NAFDAC has registered their products or to be subject to similar penalties.

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