On May 2, 2025, Concord Biotech Limited, a prominent pharmaceutical company based in India, announced the completion of an inspection by the United States Food and Drug Administration (USFDA) at its Active Pharmaceutical Ingredient (API) facility located in Dholka, Gujarat. The inspection took place from April 28 to May 2, 2025, and at its conclusion, the USFDA issued Form 483, which highlighted four observations.

According to the company’s statement, these observations are procedural in nature and do not pertain to data integrity or any major manufacturing defects. The company has assured stakeholders that it will respond to the observations within the required timeframe and is confident of addressing them in an expeditious manner.

The USFDA’s Form 483 is issued when an inspector identifies issues during the inspection that may need attention, though these observations do not always lead to significant regulatory consequences. Concord Biotech is confident that these observations will be resolved without any major disruptions to its operations or product approval processes.

As a part of the regulatory requirements, Concord Biotech provided this disclosure to the stock exchanges under Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015. This disclosure ensures that investors and stakeholders are kept informed of the developments at the company’s API facility.

Concord Biotech operates its API facility in Dholka, a significant site in the company's pharmaceutical production, which is an important part of its efforts to meet global standards for quality and safety in drug manufacturing. The company’s confidence in addressing the observations reflects its commitment to maintaining high standards of compliance and operational efficiency.

In conclusion, while the USFDA inspection has resulted in some procedural observations, Concord Biotech’s management remains confident in resolving the issues efficiently and continues to focus on delivering safe and effective pharmaceutical products to the market.

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