Dr Reddy's Hit with Rs 27 Lakh Fine in Mexico

The penalty, equivalent to MXN 6,51,420, was levied due to non-compliance with Mexico’s guidelines for import filings related to a reference standard for one of the company’s active pharmaceutical ingredients (APIs).

COFEPRIS notified Dr Reddy's of a penalty of MXN 6,51,420 "for deviation from prescribed guidelines in filing intimation of import of a reference standard for one of the company's APIs."

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In a regulatory filing, Dr Reddy’s explained that COFEPRIS cited two issues, an incorrect invoice date and a mismatch between the import license details and the reference standard’s name.

"Additionally, the fine was imposed due to an error in the date of the invoice and also name of the reference standard Vs import license, " the filing read.

Established in 1984 and headquartered in Hyderabad, Dr Reddy’s Laboratories is a major player in global pharmaceuticals. The company produces a wide array of generic medications, active pharmaceutical ingredients (APIs), and biosimilars, serving key markets like the United States, India, and Russia, as well as other emerging markets.

Dr Reddy's has a diverse therapeutic portfolio covering oncology, gastrointestinal issues, cardiovascular health, and pain management. With a strong focus on R&D, the company is committed to developing complex generics and innovative drug applications.

COFEPRIS, the Federal Commission for Protection against Health Risks, is Mexico’s regulatory agency responsible for ensuring public health standards across pharmaceuticals, food, environmental safety, and other health-related areas. It oversees drug approvals, monitors compliance with health regulations, and controls the import and export of medical and health-related products in Mexico. COFEPRIS plays a key role in protecting consumers from health risks by enforcing regulations and standards for quality and safety across various sectors.