Zydus Lifesciences Ltd

Facility details and timeline

• Joint venture between Zydus Lifesciences and Sunshine Healthcare signed with Sri Lanka BOI.
• BOI agreement to establish a manufacturing facility in Horana, Sri Lanka.
• Phased investment of over USD 20 million; first phase to manufacture oral solid dosage forms.
• Commercial operations expected to commence in 2028, subject to timelines and regulatory approvals.
• Site spans nearly four acres in BOI Horana zone.
• First phase focuses on Sri Lankan market.

USFDA Moraiya plant inspection

• USFDA inspection of Moraiya, Ahmedabad plant conducted from 5 to 13 October 2026.
• Inspection closed with five observations; company will address them expeditiously with USFDA.

Regulatory progress

• USFDA accepted the BLA for FYB206, a Keytruda biosimilar, for review.
• BLA submitted in Q3 2026; BsUFA review targets 12 months.
• First publicly announced acceptance of a Keytruda biosimilar filing by USFDA.
• Zydus retains exclusive US and Canada commercialization rights.
• Formycon retains global rights and will share gross profits.
• Decision expected in Q3 2027 under BsUFA timeline.

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.