Zydus Lifesciences Submits Q4 FY26 Compliance Certificate Under SEBI Depositories Regulations

Zydus Lifesciences Limited has submitted its quarterly compliance certificate to stock exchanges for the quarter ended March 31, 2026, in accordance with SEBI (Depositories and Participants) Regulations, 2018. The pharmaceutical company filed the mandatory certificate under regulation 74(5) with both BSE Limited and National Stock Exchange of India Limited on April 8, 2026.

Compliance Certificate Details

The certificate confirms that Zydus Lifesciences Limited has adhered to proper dematerialization procedures during the quarter. Key confirmations include:

Parameter Status Quarter Period March 31, 2026 Filing Date April 8, 2026 Regulation 74(5) of SEBI DP Regulations 2018 Stock Exchanges BSE Limited and NSE BSE Code 532321 NSE Symbol Zyduslife ISIN INE010B01027

Dematerialization Process Verification

The company confirmed that equity share certificates received for dematerialization during the quarter were properly processed. The certificate states that all physical certificates were mutilated and cancelled only after due verification, with the respective depository names substituted as registered owners for the dematerialized equity shares.

RTA Confirmation

MUFG Intime India Private Limited, formerly known as Link Intime India Private Limited, served as the company's registrar and transfer agent. The RTA provided confirmation that:

Securities received from depository participants were properly confirmed to depositories

All dematerialization procedures were completed within prescribed timelines

Security certificates were mutilated and cancelled after due verification

Depository names were substituted in the register of members as registered owners

Regulatory Compliance

The filing demonstrates Zydus Lifesciences' adherence to SEBI's depositories regulations, ensuring transparency in the dematerialization process. The certificate was signed by Dhaval N. Soni, Company Secretary and Compliance Officer, with membership number FCS7063.

Copies of the certificate were also submitted to National Securities Depository Limited and Central Depository Services (India) Limited, completing the regulatory filing requirements for the quarter ended March 31, 2026.

Zydus life science has achieved a significant regulatory milestone with the receipt of final approval from the United States Food and Drug Administration (USFDA) for its Dapagliflozin tablets. The approval covers both 5mg and 10mg tablet strengths, marking an important expansion of the company's presence in the US pharmaceutical market.

Regulatory Approval and Exclusivity Benefits

The USFDA's final approval enables Zydus Life Sciences to manufacture and market Dapagliflozin tablets in the United States. This diabetes medication represents a key addition to the company's portfolio of approved generic pharmaceuticals for the American market. With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Dapagliflozin Tablets in both approved strengths.

Parameter: Details Drug Name: Dapagliflozin Tablets Approved Strengths: 5mg and 10mg Regulatory Status: Final USFDA Approval Market Opportunity: $10.20 billion annual sales Exclusivity Period: 180 days shared generic exclusivity

Manufacturing and Market Opportunity

Dapagliflozin tablets will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad. The approval positions Zydus Life Sciences to compete in a substantial market segment, with the reference product Farxiga generating annual sales of $10.20 billion in the United States according to IQVIA MAT February data.

Drug Profile and Therapeutic Use

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. This therapeutic profile positions the medication as an important treatment option in diabetes management protocols.

Portfolio Expansion

This USFDA approval represents another step in Zydus Life Sciences' strategy to expand its generic pharmaceutical offerings in the US market. The group now has 436 approvals and has filed 505 ANDAs since commencing the filing process. The company continues to build its presence in key therapeutic areas, with diabetes medications representing an important segment given the growing patient population and treatment needs.

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