Kunal Dhamesha

Neha Manpuria

Surya Patra

Tushar Manudhane

Amey Chalke

Bino Pathiparampil

Madhav Marda

Abdulkader Puranwala

Damayanti Kerai

Saion Mukherjee

Shashank Krishnakumar

Shyam Srinivasan

Abdul Kader Puranwala

Aman Witch

Ankush Mahajan

Balaji Prasad

Foram Parekh

Harith Ahamed

Jainil Shah

Nitish Dutt

Shrikant Akolkar

Tarang Agrawal

- On **September 22, 2025**, Dr. Reddy's Laboratories Ltd. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a **positive opinion** recommending marketing authorisation for **AVT03**, a biosimilar of Prolia® and Xgeva® in European markets.  **[1135951_0001575872-25-000589_rdy0807_ex99-1.htm:0]** **[1135951_0001575872-25-000589_rdy0807_ex99-1.htm:1]** 
- The CHMP's positive opinion will now proceed to the European Commission (EC) for a final decision on marketing authorisation in the European Economic Area (EEA), with a separate application planned for the UK.  **[1135951_0001575872-25-000589_rdy0807_ex99-1.htm:1]** 
- Under a **May 2024** license and supply agreement with Alvotech, Dr. Reddy's holds **exclusive commercialization rights for AVT03 in the U.S.** and **semi-exclusive rights for Europe and the UK**.  **[1135951_0001575872-25-000589_rdy0807_ex99-1.htm:1]** 
- Upon approval, Dr. Reddy's intends to offer the biosimilar under the tradenames **Acvybra®** (denosumab) and **Xbonzy®** (denosumab).  **[1135951_0001575872-25-000589_rdy0807_ex99-1.htm:1]**

Dr. Reddy's receives positive European regulatory opinion for biosimilar AVT03

- Dr. Reddy's Laboratories Ltd. announced the **launch of its novel molecule Tegoprazan** (brand name **PCAB®**) in India on **September 16, 2025**, for the treatment of **acid-related gastrointestinal diseases**.  **[1135951_0001575872-25-000578_rdy0804_ex99-1.htm:0]** **[1135951_0001575872-25-000578_rdy0804_ex99-1.htm:1]** 
- Tegoprazan is a **next-generation potassium-competitive acid blocker** and was launched following an **exclusive partnership established in 2022** with South Korea-based HK inno.N Corporation.  **[1135951_0001575872-25-000578_rdy0804_ex99-1.htm:1]** 
- The molecule addresses a significant medical need, as acid peptic diseases affect approximately **38% of the Indian population**, and it demonstrated **99% endoscopic healing** in GERD patients during a multinational clinical trial.  **[1135951_0001575872-25-000578_rdy0804_ex99-1.htm:1]**

Dr. Reddy's Launches Novel Molecule Tegoprazan in India

- The **United States Food & Drug Administration (USFDA)** completed a Pre-Approval Inspection (PAI) at Dr. Reddy's biologics manufacturing facility in Bachupally, Hyderabad.  **[1135951_0001575872-25-000572_rdy0802_ex99-1.htm:0]** 
- The inspection was conducted from **September 4, 2025, to September 12, 2025**.  **[1135951_0001575872-25-000572_rdy0802_ex99-1.htm:0]** 
- Dr. Reddy's Laboratories was issued a **Form 483 with five observations** following the inspection.  **[1135951_0001575872-25-000572_rdy0802_ex99-1.htm:0]** 
- The company has stated it will **address these observations within the stipulated timeline**.  **[1135951_0001575872-25-000572_rdy0802_ex99-1.htm:0]**

Dr. Reddy's Laboratories' biologics facility receives USFDA Form 483

- Dr. Reddy's Laboratories Limited has entered into a definitive agreement with **Janssen Pharmaceutica NV**, an affiliate of Johnson & Johnson, to acquire the **STUGERON® brand portfolio** and its related assets.  **[1135951_0001575872-25-000570_rdy0801_ex99-1.htm:0]** **[1135951_0001575872-25-000570_rdy0801_ex99-1.htm:1]** 
- The acquisition covers **18 markets** in the Asia-Pacific (APAC) and Europe, Middle East, and Africa (EMEA) regions, with **India and Vietnam** identified as key markets.  **[1135951_0001575872-25-000570_rdy0801_ex99-1.htm:0]** **[1135951_0001575872-25-000570_rdy0801_ex99-1.htm:1]** 
- The consideration paid for this acquisition is **USD 50.5 million**.  **[1135951_0001575872-25-000570_rdy0801_ex99-1.htm:0]** 
- This strategic move is intended to strengthen Dr. Reddy's **Central Nervous System (CNS) Portfolio** by expanding into the **anti-vertigo therapeutic segment**.  **[1135951_0001575872-25-000570_rdy0801_ex99-1.htm:0]** **[1135951_0001575872-25-000570_rdy0801_ex99-1.htm:1]**

Dr. Reddy's Acquires STUGERON® Brand Portfolio for $50.5 Million

DR REDDYS LABORATORIES (RDY)