Caplin point laboratories Limited has submitted its quarterly compliance certificate to stock exchanges, fulfilling regulatory obligations under SEBI (Depositories and Participants) Regulations, 2018. The pharmaceutical company filed the mandatory certificate for the quarter ended March 31, 2026, demonstrating adherence to securities market compliance requirements.

Regulatory Compliance Submission

The company submitted the certificate under Regulation 74(5) of SEBI (Depositories and Participants) Regulations, 2018 to both BSE Limited and National Stock Exchange of India Ltd on April 06, 2026. This quarterly submission is a mandatory requirement for listed companies to ensure transparency in securities handling and dematerialisation processes.

Registrar Confirmation

Integrated Registry Management Services Private Limited, serving as the company's Registrar and Transfer Agent, issued the compliance certificate on April 03, 2026. The registrar confirmed that all securities received from Depository Participants for dematerialisation during Q4FY26 were properly processed and confirmed to depositories and stock exchanges.

The certificate validates several key compliance aspects:

• Securities received for dematerialisation were confirmed within regulatory timelines
• All security certificates were mutilated and cancelled after due verification
• Depository names were substituted in the register of members as registered owners
• All processes were completed within the mandated 15-day period

Corporate Governance

Venkatram G, General Counsel & Company Secretary (Membership No A23989), signed the submission on behalf of Caplin Point Laboratories Limited. The digital signature was applied on April 06, 2026, ensuring proper authentication and compliance with electronic filing requirements.

This quarterly submission reinforces the company's commitment to maintaining regulatory compliance and transparency in securities operations, ensuring investor confidence through proper adherence to SEBI regulations.

Caplin point laboratories has received final approval from the United States Food and Drug Administration (USFDA) for Potassium Phosphates Injection USP through its subsidiary, Caplin Steriles Limited. The approval was announced in a regulatory filing under Regulation 30, marking a significant milestone for the pharmaceutical company's US market expansion.

Product Details and Market Opportunity

The USFDA granted approval for the Abbreviated New Drug Application (ANDA) for Potassium Phosphates Injection USP, containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL in 5 mL, 15 mL and 50 mL vials. This generic version serves as a therapeutic equivalent to the Reference Listed Drug from Fresenius Kabi USA, LLC.

According to IQVIA data, the product recorded US sales of approximately $57 million for the 12-month period ending January 2026, indicating substantial commercial potential in this therapeutic segment.

Therapeutic Applications

Potassium Phosphates Injection is used as a source of phosphorus in intravenous fluids to correct hypophosphatemia and as parenteral nutrition in adults and pediatric patients who cannot take oral supplements. This positions the product in the critical care and hospital segment of the pharmaceutical market.

Strategic Significance

This regulatory milestone strengthens Caplin Point Laboratories' position in the US pharmaceutical market, particularly in the sterile injectables segment. Caplin Steriles Limited has developed and filed 54 ANDAs in the USA, achieving 53 approvals including acquired ANDAs. The subsidiary maintains approvals from multiple regulatory agencies including US FDA, EU-GMP, ANVISA and INVIMA.

The company is working on a portfolio of 55+ simple and complex injectable and ophthalmic products intended for filing over the next four years, demonstrating its commitment to expanding its US market presence.