Alkem Laboratories has received a favourable Order-in-Appeal from the Commissioner (Appeals) -II CGST & C.Ex, Mumbai, under the Goods and Services Tax Act, 2017. The order was received on 4th May 2026 and was disclosed to the stock exchanges on 5th May 2026 pursuant to Regulation 30 read with Schedule III of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. This disclosure follows an earlier intimation dated 4th February, 2025.

GST Demand Dropped by Appellate Authority

The Order-in-Appeal results in the dropping of a GST demand of Rs. 69,65,52,636/- along with applicable interest and penalty of Rs. 69,65,52,636/- under the applicable provisions of the IGST Act, 2017, CGST Act, 2017, and SGST Act, 2017. The original demand had been raised on the grounds of alleged incorrect availment of Input Tax Credit (ITC) and/or payment of GST refund. The favourable appellate order effectively nullifies the financial liability that had been contested by the company.

Key Details of the Order

The following table summarises the key particulars of the Order-in-Appeal as disclosed by the company:

No Material Impact on Company Operations

Alkem Laboratories has stated that the order has no material impact on the financial, operational, or other activities of the company. The disclosure was made by Manish Narang, President – Legal, Company Secretary & Compliance Officer, in accordance with Clause 20 of Para A of Part A of Schedule III of the SEBI Listing Regulations. The company also noted that any delay in disclosure was inadvertent and not intentional.

Alkem Laboratories has notified stock exchanges about a recent US FDA inspection at its manufacturing facility located in Amaliya, Daman. The pharmaceutical company disclosed that the regulatory inspection resulted in Form 483 observations that require remedial action.

FDA Inspection Details

The US FDA conducted a comprehensive inspection of Alkem's Daman manufacturing facility over an 11-day period. The inspection timeline and outcomes are detailed below:

Regulatory Compliance Response

Following the completion of the FDA inspection, Alkem Laboratories received Form 483 containing seven specific observations. Form 483 is issued by the FDA to document conditions or practices that may constitute violations of the Food, Drug and Cosmetic Act and related regulations.

The company has formally committed to addressing all identified observations within the timeframe stipulated by regulatory requirements. This response demonstrates Alkem's commitment to maintaining compliance with international pharmaceutical manufacturing standards.

Corporate Communication

Alkem Laboratories communicated this development to both major Indian stock exchanges on May 2, 2026. The disclosure was made to BSE Limited and National Stock Exchange of India Limited as part of the company's regulatory reporting obligations. The communication was signed by Manish Narang, President-Legal, Company Secretary and Compliance Officer, ensuring proper corporate governance protocols were followed in the disclosure process.