Alkem Laboratories has informed the stock exchanges that the United States Food and Drug Administration (US FDA) conducted an unannounced inspection at the company's Contract Research Organisation (CRO) facility located in Taloja, Maharashtra, on May 8, 2026. The inspection concluded without the issuance of a Form 483, signalling a clean outcome for the facility.

US FDA Inspection at Taloja CRO Facility

The unannounced inspection was carried out by the US FDA on May 8, 2026, at Alkem Laboratories' CRO facility in Taloja, Maharashtra. A Form 483 is issued by the US FDA when investigators observe conditions that may constitute violations of regulations during an inspection. The absence of a Form 483 at the conclusion of this inspection indicates that no objectionable conditions or regulatory violations were noted by the inspecting authority.

Key details of the inspection are summarised below:

Regulatory Disclosure

The disclosure was made to both BSE Limited and the National Stock Exchange of India Limited in compliance with applicable listing regulations. The communication was signed by Manish Narang, President – Legal, Company Secretary and Compliance Officer of Alkem Laboratories Limited, confirming the outcome of the inspection on the same day it was conducted.

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.