AUROBINDO PHARMA LTD.

Aurobindo Pharma Ltd has announced a Board of Directors meeting scheduled for November 4, 2026. The meeting will primarily focus on approving the standalone and consolidated unaudited financial results for the second quarter and half-year ended September 30, 2026. Additionally, the board will consider the payment of an interim dividend for the financial year 2026-27. The trading window, initially closed from October 1, 2026, will remain closed until November 6, 2026, and will reopen on November 7, 2026.

Aurobindo Pharma Limited announced it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Perampanel Tablets in various dosages (2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg). These tablets are bioequivalent and therapeutically equivalent to Catalyst Pharmaceuticals' Fycompa® Tablets. The product will be manufactured at Aurobindo's wholly-owned subsidiary, APL Healthcare's Unit-IV, and is slated for launch in Q3FY27. The approved product targets an estimated market size of US$ 67 million. This approval adds to Aurobindo's portfolio, bringing their total USFDA ANDA approvals to 599 (574 final, 25 tentative). Perampanel Tablets are indicated for epilepsy treatment.

Aurobindo Pharma Ltd announced the completion of the acquisition of the Contract Research Services business of A1 Biochem Group by its wholly owned subsidiary, Apitoria Pharma Private Limited. This acquisition involves Apitoria holding 80% ownership in A1 Biochem Labs (India) Private Limited ('A1 Labs India'), with the remaining 20% held by Dr. Rajendra Gadikota. A1 Labs India, through its US subsidiary, has acquired 100% of A1 Biochem Labs LLC, USA. This strategic move provides Apitoria with access to an established CRO platform with over 50 clients and extensive project experience in India and the USA. The acquisition is expected to complement Apitoria's manufacturing capabilities, creating an integrated CRDMO platform and broadening its service offerings and customer engagement.

Aurobindo Pharma Ltd, through its wholly owned subsidiary Apitoria Pharma Private Limited, has acquired 100% ownership of A1 Biochem Labs LLC (A1 Labs LLC) in the USA. A1 Labs LLC, based in Wilmington, North Carolina, provides contract research and chemistry services to pharmaceutical and biotechnology companies. The acquisition aligns with Aurobindo Pharma's strategy to expand its Active Pharmaceutical Ingredients (API) business and create a dedicated Contract Research, Development and Manufacturing (CRDMO) platform. A1 Labs LLC reported sales of USD 9.23 Million in CY2024 and USD 5.92 Million in CY2025. The transaction is considered a related party transaction as A1 Labs LLC is being acquired from Dr. Rajendra Gadikota, a Director of A1 Labs India, but is being undertaken at arm's length. No governmental or regulatory approvals are required for this acquisition.

Aurobindo Pharma Ltd announced that its step-down subsidiary, A1 Biochem Labs (India) Private Limited (A1 Labs), has allotted equity shares and compulsory convertible debentures to Dr. Rajendra Gadikota, the former promoter of A1 Biochem group. This transaction results in Dr. Gadikota holding a 20% stake in A1 Labs on a fully diluted basis, thereby ceasing its status as a wholly-owned subsidiary. The allotment involved 89,94,500 equity shares and 2,41,05,500 Compulsory Convertible Debentures, for which A1 Labs received ₹9.18 Cr and ₹24.62 Cr respectively, totaling ₹33.80 Cr. A1 Labs continues to be a subsidiary of Apitoria Pharma Private Limited (a wholly owned subsidiary of Aurobindo Pharma) and a step-down subsidiary of Aurobindo Pharma. The transaction is considered a related party transaction but has been conducted at arm's length, based on a fair valuation report and shareholder approval.

Aurobindo Pharma's subsidiary, Acrotech Biopharma, has launched ADQUEY™ (difamilast 1%) ointment in the U.S. market. This non-steroidal topical treatment is for mild-to-moderate atopic dermatitis in adults and pediatric patients aged 2 years and older. The launch signifies Acrotech's entry into the U.S. dermatology sector and is supported by the establishment of a dedicated dermatology business unit. The market for this treatment is estimated at US$ 1.3 billion. ADQUEY was originally discovered by Otsuka Pharmaceutical and licensed to Acrotech for U.S. commercialization. This move aligns with Acrotech's strategy to expand its portfolio of innovative medicines.

Aurobindo Pharma Ltd has received an order from the Appellate Joint Commissioner (ST), Hyderabad, confirming a demand for reversal of alleged excess Input Tax Credit (ITC) amounting to ₹2,56,44,999. This includes CGST of ₹81,04,008, SGST of ₹81,04,008, and IGST of ₹94,36,983. Additionally, the company is liable for interest of ₹1,78,19,409 and a penalty of ₹25,64,500, bringing the total disputed amount to ₹4,60,28,908. The order pertains to the financial year 2020-21 and relates to an alleged excess ITC claim in GSTR 3B compared to GSTR 2A. The company stated there is no material impact on its financials or operations and intends to file an appeal before the GST Appellate Tribunal.

Aurobindo Pharma Ltd has announced the closure of its trading window for all designated persons, including promoters, directors, and key managerial personnel. This closure is in accordance with the company's Internal Code of Conduct for trading by designated persons. The trading window will be shut from October 1, 2026, until 48 hours after the declaration of the unaudited financial results for the second quarter and half-year ending September 30, 2026. The specific date for the board meeting to approve these financial results will be communicated later.

Apitoria Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, has successfully completed a US FDA inspection of its Unit-II API manufacturing facility in Telangana. The inspection, conducted from September 7th to September 15th, 2026, concluded with a single procedural observation. Aurobindo Pharma stated that they will respond to the US FDA within the stipulated timeline and are committed to maintaining high quality and compliance standards. Further developments will be communicated as required.

Aurobindo Pharma has received final approval from the USFDA for its Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcg. This marks the company's first metered-dose inhaler (MDI) product, signifying an expansion into complex respiratory therapies. The product, a generic equivalent of QVAR® Inhalation Aerosol, will be manufactured at Aurobindo's US facility. The US market for this product category was estimated at $301 million. This approval brings Aurobindo's total USFDA ANDA approvals to 596, strengthening its portfolio of complex products. The product is indicated for the maintenance treatment of asthma in patients aged 5 years and older and is expected to launch in upcoming quarters.