Zydus Lifesciences Ltd

USFDA inspection outcome

• USFDA conducted a cGMP inspection at SEZ II Ahmedabad from 21 to 28 September 2026.
• The inspection closed with one observation; no data integrity-related observations.
• The company will closely work with USFDA to address the observation expeditiously.

Zydus Lifesciences Limited trading window closed from Thursday, October 1, 2026 till 48 hours after the declaration of unaudited financial results for the quarter / half year ending on September 30, 2026.

Regulatory update

• US FDA conducted onsite pharmacovigilance and post-marketing system inspection at Zydus' New Jersey office from Sep 22–25, 2026.
• Inspection concluded with NIL observations.

Instruments Rated

• Bank facilities: Rs 4,724 crore; long-term AAA/Stable and short-term A1+ (reaffirmed).
• Commercial Papers: Rs 200 crore; A1+ (reaffirmed).
• Non-Convertible Debentures: Rs 50 crore; AAA/Stable (reaffirmed).
• Debentures: Rs 75 crore; AAA/Stable (reaffirmed).

Rating Agency

• CRISIL Ratings Limited; ratings reaffirmed with surveillance.

Rationale

• AAA/Stable long-term rating indicates highest safety and lowest credit risk.
• Ratings based on information provided by the issuer; kept under continuous surveillance.

Outlook

• Long-term outlook: Stable; no change in outlook for affirmed ratings.

Material changes

• No material change; ratings reaffirmed across all instruments.

Financial highlights

• Total bank facilities rated: Rs 4,724 crore.

Meeting Details

• Date: September 21, 2026 (time not specified).
• Type: investor conference; mode not specified.
• Event: J.P. Morgan India Conference 2026.
• Purpose: participate in investor conference.
• Key company participants: not specified.

AGM Details

• Date/time: Aug 11, 2026, 10:00–11:16 IST; conducted via Video Conferencing.
• Mode: VC per MCA/SEBI circulars.
• Voting cut-off: Aug 4, 2026; remote e-voting Aug 8–10, 2026.
• Notice: May 19, 2026; AGM concluded Aug 11, 2026.

Resolutions & Voting (ordinary vs special)

• Adoption of standalone financial statements; Ordinary.
• Adoption of consolidated financial statements; Ordinary.
• Dividend declaration at Re 1 per share; Ordinary.
• Re-appointment of Pankaj Patel as director; Ordinary.
• Re-appointment of Mukesh Patel as director; Ordinary.
• Cost Auditors remuneration ratified for FY2027; Ordinary.
• Re-appointment of Sharvil Patel as MD for 5 years; Ordinary.
• Appointment of Kulin Lalbhai as Independent Director for 5 years; Ordinary.
• Payment of commission to non-executive directors; Ordinary.

Dividend

• Dividend declared: Re 1 per share for FY2025-26.

Director Changes & Appointments

• Kulin Lalbhai added as additional Independent Director; subject to approval.
• Kulin Lalbhai to sit on Audit, Nomination & Remuneration, Risk Committees.
• Sharvil Patel reappointed as MD for 5 years (2027–2032).
• Pankaj Patel reappointed as director; retires by rotation.
• Mukesh Patel reappointed as director; retires by rotation.

Auditors

• Statutory Auditor remains; no change.
• Cost Auditors remuneration ratification for FY2027.
• Secretarial Scrutinizer: Ashish Doshi appointed.

Material Related Party Transactions

• No material related party transactions disclosed.

Other Material Approvals

• Board approved share buyback up to Rs 1,100 crore at Rs 1,260 per share.
• Acquisitions: Comfort Click Limited; Amplitude Surgical integration.
• R&D spend around 8% of revenue; ongoing AI initiatives.

Event summary

• Topline results: EVIDENCES-X Phase II(b) trial completed with positive outcome.
• Primary endpoint achieved: resolution of steatohepatitis with no fibrosis worsening.
• 189 patients randomized to Saroglitazar 2 mg, 4 mg or placebo over 52 weeks.

Additional results and development

• Improvements observed in liver histology, steatosis, inflammation, and ballooning.
• Results to be presented at Liver Congress; prior Phase II data published.

Regulatory context

• DCGI approved Saroglitazar Mg in 2020 for MASH/MASLD in India; no US/EMA approvals yet.
• MASLD affects about 25% of adults; MASH affects 5–20%.

Trial leadership

• Trial led by Prof. Naga Chalasani and Prof. Arun J. Sanyal.