Caplin Steriles Limited (CSL), a subsidiary of Caplin Point Laboratories , announced on May 05, 2026, that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Calcium Gluconate Injection USP. The approval covers the 100 mg/mL formulation available in 10 mL, 50 mL, and 100 mL vials, representing a generic therapeutic equivalent of the Reference Listed Drug (RLD) from Fresenius Kabi USA, LLC (NDA 208418).

Approval Details

The following table summarises the key parameters of the USFDA approval received by Caplin Steriles Limited:

Therapeutic Indication and Market Size

Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. According to IQVIA™ (IMS Health), Calcium Gluconate Injection USP (100 mg/mL in 10 mL, 50 mL and 100 mL Vials) recorded US sales of approximately $71 million for the 12-month period ending March 2026.

About Caplin Steriles Limited

Caplin Steriles Limited is a fast-growing sterile product manufacturing company approved by several regulatory agencies, including US FDA, EU-GMP, ANVISA, and INVIMA. Key highlights of CSL's regulatory and pipeline profile include:

• 54 ANDAs filed in the USA on its own and with partners, with 54 approvals (including acquired ANDAs) so far
• A portfolio of 55+ simple and complex Injectable and Ophthalmic products intended to be filed over the next 4 years
• Multiple products filed with several approvals in non-US markets including Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, South Africa, and Saudi Arabia

About Caplin Point Laboratories Limited

Caplin Point Laboratories Limited is a pharmaceutical company with a business model catering predominantly to emerging markets of Latin America and Africa, with state-of-the-art manufacturing facilities covering a complete range of finished dosage forms. The company has appeared on Forbes "Asia's 200 Best Under a Billion" list for 7 times in the last 10 years, and was awarded "The Emerging Company of 2018" and "Business Excellence Award for 2019" by Economic Times.

Caplin One Labs Limited (COL), another subsidiary of Caplin Point Laboratories Limited, is in the second year of its operations at its oncology unit in Kakkalur, with various ongoing projects in different stages of completion for generic and specialty products for both regulated and other markets. COL holds 5 approved ANDAs for Injectable products.

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.