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- USFDA has accepted the Biologics License Application (BLA) for FYB206, a proposed biosimilar to Keytruda (pembrolizumab), for review. - To the companies' knowledge, this is the first publicly announced acceptance by the USFDA of a filing for a Keytruda biosimilar. - Zydus holds exclusive commercialization rights for the US and Canada under a licensing and supply agreement with Formycon.

Zydus Lifesciences presented a post hoc analysis of the Phase 3 EPICS-III trial at ACG 2026 for investigational saroglitazar in primary biliary cholangitis (PBC). - Results showed greater biochemical response with saroglitazar compared to placebo across geographic subgroups, with a numerically higher response in U.S. patients versus non-U.S. patients. - Saroglitazar is currently under review by the U.S. FDA, with a planned launch by March 2027 if approved.

Order Win: Zydus Lifesciences and MSN Laboratories launched the first generic version of Adempas (Riociguat Tablets) in the U.S. across all five strengths (0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg). Details: Adempas global sales reached approximately EUR 745 million (USD 850 million) in 2025 according to Bayer's Annual Report.

- Zydus Lifesciences and Sunshine Healthcare Lanka have mutually agreed to extend the closing date for completing the condition precedents of their 50:50 joint venture, Zydus Sunshine Lifesciences. - The transaction completion timeline is now extended to December 2026.

- USFDA conducted a cGMP inspection at Zydus' manufacturing plant at SEZ II, Ahmedabad from September 21 to 28, 2026. - The inspection concluded with a single observation and no data integrity related observations. - The company will work closely with the USFDA to address the observation expeditiously.

- Trading window will remain closed from October 1, 2026, until 48 hours after the declaration of unaudited financial results for the quarter/half-year ending September 30, 2026. - Applies to Directors, Designated Persons, and their immediate relatives. - Board meeting date for approving results will be intimated later.

- USFDA inspection of pharmacovigilance and post marketing surveillance system concluded at Zydus' USA Office in New Jersey. - The inspection took place from September 22nd to September 25th, 2026. - The inspection successfully closed with NIL observations.

- CRISIL Ratings reaffirmed credit ratings for Zydus Lifesciences Limited's various instruments on September 10, 2026. - Bank facilities (₹4,724 Cr) rated CRISIL AAA/Stable (long-term) and CRISIL A1+ (short-term). - Commercial Papers (₹200 Cr) rated CRISIL A1+. - Non-Convertible Debentures (₹125 Cr combined) rated CRISIL AAA/Stable. - Ratings indicate a very strong degree of safety and lowest credit risk.

- Investor Conference - Company: Zydus Lifesciences Limited - Event: J.P. Morgan India Conference, 2026 - Date: September 21, 2026

- Zydus Lifesciences announced positive topline results from its EVIDENCES-X Phase II(b) clinical trial of Saroglitazar Mg in MASH. - The trial successfully met its primary endpoint of steatohepatitis resolution with no worsening of fibrosis. - This is a significant milestone for their MASH development program.

- Zydus Lifesciences Limited incorporated a wholly owned subsidiary, Zydus Global Treasury Centre IFSC Limited, on August 25, 2026. - The 'Gift City Company' in Gandhinagar, Gujarat, will undertake global/regional corporate treasury activities and services. - The subsidiary is 100% owned with a paid-up share capital of Rs. 5 Crores.

- CRISIL Ratings assigned Zydus Lifesciences an overall ESG Score of 66 for FY 2025-2026. - The previous score was 61, indicating an improvement. - CRISIL considers a score between 61-70 as 'strong'.

- Mr. Prashant Babubhai Patel, Member of the Promoter Group, received 32,577 equity shares via transmission from Late Jasodaben Babubhai Patel, also a Member of the Promoter Group. The off-market transaction occurred on August 19, 2026.

- Zydus Lifesciences Ltd submitted its investor presentation for a conference on August 24-26, 2026. The presentation highlights strong financial performance with FY26 Revenue of INR 2,71,484 Mn, EBITDA of INR 84,751 Mn (31.2% margin), and PAT of INR 54,564 Mn (20.1% margin), reflecting consistent growth and a diversified global portfolio.

- Zydus Lifesciences Limited received an overall ESG rating of 60 from ESGRAIL, a SEBI registered ESG Rating Provider. - The company stated that it had not engaged ESGRAIL for this independent rating, which was based on publicly available information.

- Zydus Lifesciences received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection USP. - The product has been designated as a Competitive Generic Therapy (CGT), granting 180-day exclusivity. - The brand product had annual sales of approximately USD 11.6 million in the United States as per IQVIA MAT June-2026. - The product will be manufactured at the company's USFDA-approved injectable plant in Jarod, Gujarat, and marketed in the US.

- Commenced FY27 with strong double-digit growth, registering consolidated revenues of ₹80.2 billion (▲22% YoY) and an EBITDA margin of 24.1%. Net profit for Q1 FY27 was ₹9.4 billion. - India branded formulations business grew 20% YoY, outpacing market; mid-teens growth expected for FY27. - International markets formulations business posted revenues of ₹9.7 billion (▲34% YoY); North America business revenues were ₹31 billion (▲5% QoQ). - Consumer Wellness business recorded revenues of ₹14.3 billion (▲67% YoY), with double-digit growth expected for FY27. - Maintained guidance for strong double-digit revenue growth and 24%+ EBITDA margin for FY27, with long-term target of 28-30% EBITDA margin within 5 years. - FY27 Capex is guided around ₹1,500-₹1,600 crores for facility expansion and R&D initiatives. - Key strategic initiatives include the launch of Nufymco™ (first US biosimilar), acquisition of Assertio Holdings, and progress on Saroglitazar Magnesium NDA (USFDA priority review, FY28 launch with $200-$400+ million potential). - Significant R&D pipeline advancements across biosimilars, vaccines, and NCEs, including Phase III trials for Desidustat (sickle cell disease) and a second ADC Biosimilar. - Planned 30-40 US product launches for FY27, with US branded business expected to contribute over 15% of US revenue by year-end.

- Zydus Lifesciences management will meet investors in Singapore and Hong Kong for a Non-Deal Roadshow (NDR). - The investor conference is scheduled from August 24 to August 26, 2026.

- Zydus Lifesciences Limited's participation in the Motilal Oswal 22nd Annual Global Investor Conference, 2026, has been rescheduled. - The conference will now be held on August 17, 2026, instead of August 18, 2026.

- Zydus Lifesciences Limited announced voting results of its 31st Annual General Meeting held on August 11, 2026. - All resolutions were passed, including the adoption of financial statements, declaration of a final dividend of ₹1/- per equity share, and re-appointments of directors.

- Re-appointment of Dr. Sharvil P. Patel as Managing Director for a further five years (April 1, 2027 to March 31, 2032). - Appointment of Mr. Kulin S. Lalbhai as an Independent Director for a term of five years (May 19, 2026 to May 18, 2031). - Both resolutions were passed at the 31st Annual General Meeting held on August 11, 2026.