Alkem Laboratories denies claims of Pan-D, Clavam 625 batches being not-of-standard quality

The samples of both products mentioned in the CDSCO list are spurious and not manufactured by Alkem

Alkem gives utmost importance to quality and patient safety. All products manufactured at our sites follow the current good manufacturing practices (cGMP)

India, 2024: Alkem Laboratories Ltd. (BSE: 539523, NSE: ALKEM, “Alkem” and includes its associate companies and/or subsidiaries), denies claims that batches of its products Pan-D and Clavam 625 are not-of-standard quality (NSQ), as reported by several media publications and channels based on a list issued by the Central Drugs Standard Control Organization (CDSCO).

The media reports refer to the CDSCO East Zone, Kolkata’s update that mentioned one batch of Pan-D capsules (Batch No. #23444296) and one batch of Clavam 625 tablets (Batch No. #23443940), among many other drugs of other pharmaceutical companies, as allegedly being not-of-standard quality.

Alkem conducted a thorough investigation by comparing the samples collected by the CDSCO with the actual batches of both products manufactured by Alkem and found that the samples picked by the CDSCO were spurious and not manufactured by Alkem. The conclusion is based on the differences observed between the CDSCO samples and the actual batches manufactured by Alkem in terms of physical appearance, colour and text in the labelling of the two products. Alkem has already submitted a response to the CSDCO, along with the assessment report which confirmed that samples collected by CDSCO are spurious and not manufactured by Alkem.

Alkem remains committed to following the highest quality standards and the current good manufacturing practices (cGMP) for all its products. To tackle the spurious drugs issues, Alkem has incorporated unique features and QR codes in its packaging of both Pan-D and Clavam 625, which separates the genuine products from the spurious ones.