Pharmaceutical company tells PSX that Punjab’s drug alert relates to counterfeit Azomax and confirms its genuine product remains safe and fully compliant.
KARACHI: AGP Limited has clarified that a recent government alert concerning Azomax® (Azithromycin) relates solely to a counterfeit product and does not involve the genuine medicine manufactured by the company.
In a material information notice submitted to the Pakistan Stock Exchange (PSX) on Monday, AGP Limited said reports circulating on electronic and social media had incorrectly suggested that its Azomax product had been declared substandard or unsafe following the issuance of Prompt Alert No. 97/2026 by the Directorate of Drugs Control, Government of Punjab.
The company said the misleading reports had the potential to create unnecessary confusion among investors, healthcare professionals and the public, prompting it to issue an official clarification.
Counterfeit product identified
According to AGP, the Punjab government’s alert specifically relates to a counterfeit product bearing the Azomax® name and Batch No. H5332, which was recovered during routine market surveillance from an unauthorised individual operating outside the company’s authorised distribution network.
The company pointed out that the official alert itself states the seized medicine was only “purported to be manufactured by M/s AGP Limited” and explicitly confirms that it does not belong to the genuine manufacturer.
Following receipt of the recovered samples from the relevant regulatory authorities, AGP said it immediately initiated an extensive product authentication process.
The verification included examination of the product’s packaging, printing characteristics, proprietary security features, serialisation details through 2D barcoding, and manufacturing specifications.
After completing its investigation, the company confirmed that the recovered samples had not been manufactured by AGP Limited.
It subsequently submitted its authentication findings and comparative analysis to the competent regulatory authorities and requested legal and regulatory action against those involved in manufacturing and distributing the counterfeit medicine.
No impact on product quality or operations
AGP emphasised that the incident does not involve a manufacturing defect, product quality failure, product recall or any regulatory action against the company or its products.
The company stated that the counterfeit case has no impact on its manufacturing operations, regulatory approvals, commercial activities or business continuity.
It added that all AGP medicines continue to be produced at Good Manufacturing Practices (GMP)-compliant facilities and are subject to rigorous quality assurance and quality control procedures in accordance with applicable regulatory standards.
Anti-counterfeit security measures
Highlighting the market position of its flagship antibiotic brand, AGP said Azomax generates annual sales exceeding Rs5 billion and continues to enjoy the confidence of healthcare professionals and patients.
The company noted that Azomax packaging incorporates multiple anti-counterfeit features, including:
• A colour-shifting OBS AGP security logo;
• CRISMA security technology embedded in the brand name;
• Covert machine-readable security printing; and
• A unique serialised Track & Trace system that enables authentication of every individual pack throughout the supply chain.
Commitment to patient safety
AGP reaffirmed its commitment to working closely with the Drug Regulatory Authority of Pakistan (DRAP), provincial drug control authorities and law enforcement agencies to combat counterfeit medicines and safeguard Pakistan’s pharmaceutical supply chain.
The company also reserved its legal rights against individuals or entities involved in manufacturing counterfeit products or disseminating false, misleading or defamatory information that could damage its reputation or mislead healthcare professionals, patients, investors and the public.
AGP said the clarification was issued to ensure shareholders, investors, healthcare professionals, pharmacists and patients receive accurate information and are not influenced by misinformation surrounding the government’s counterfeit drug alert.