Caplin Point Laboratories Limited has informed stock exchanges about the cessation of Dr. C K Gariyali as an Independent Director, effective from the close of business hours on March 03, 2026. The announcement was made in compliance with Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Board Change Details

The cessation follows the completion of Dr. Gariyali's maximum permitted tenure as an Independent Director. According to the company's disclosure, she had served her second term as an Independent Director and ceased her role in accordance with the terms of her appointment.

Regulatory Compliance

Caplin Point Laboratories has filed the requisite disclosure with both BSE Limited and National Stock Exchange of India Ltd. The communication was signed by Venkatram G, General Counsel & Company Secretary (Membership No. A23989), ensuring proper compliance with regulatory requirements.

Corporate Governance Framework

The cessation aligns with corporate governance norms that limit the tenure of Independent Directors to ensure board independence and fresh perspectives. The company has followed due process in accordance with SEBI Master circular HO/49/14/14(7)2025-CFD-POD2/I/3762/2026 dated January 30, 2026.

The pharmaceutical company continues to maintain its commitment to regulatory compliance and transparent disclosure practices through timely communication with stakeholders and stock exchanges.

Caplin point laboratories subsidiary Caplin Steriles Limited has secured final approval from the United States Food and Drug Administration (USFDA) for its Desmopressin Acetate Injection USP. The approval covers both 4 mcg/mL single-dose vials and 40 mcg/10 mL (4 mcg/mL) multiple-dose vials, positioning the company to enter a significant therapeutic market.

USFDA Approval Details

The approved Abbreviated New Drug Application (ANDA) represents a generic therapeutic equivalent version of the Reference Listed Drug (RLD) DDAVP (desmopressin acetate) Injection manufactured by Nordic Pharma Inc. The approval announcement was made on February 28, 2026, through official communications to BSE Limited and National Stock Exchange of India Ltd.

Market Opportunity and Therapeutic Applications

Desmopressin Acetate Injection serves critical medical applications in treating haemophilia A, von Willebrand disease, and central diabetes insipidus. The medication helps manage bleeding disorders and regulate urine production in patients with these conditions.

According to IQVIA data, Desmopressin Acetate injection USP had US sales of approximately $26 million for the 12-month period ending December 2025. This market size represents a substantial opportunity for Caplin Steriles to expand its presence in the US injectable pharmaceutical market.

Company Portfolio and Regulatory Standing

Caplin Steriles Limited operates as a fast-growing sterile product manufacturing company with approvals from multiple regulatory agencies including US FDA, EU-GMP, ANVISA, and INVIMA. The subsidiary has demonstrated strong regulatory capabilities with an impressive ANDA portfolio.

The company maintains a diversified geographic presence with multiple product approvals in non-US markets including Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, South Africa, and Saudi Arabia.

Corporate Structure and Recognition

Caplin Point Laboratories Limited operates with a unique business model focusing predominantly on emerging markets of Latin America and Africa. The parent company has achieved consistent growth in cash flows, profitability, and revenues over the past 15 years.

Notable achievements include:

• Featured on Forbes "Asia's 200 Best Under a Billion" list for 7 times in the last 10 years
• Awarded "The Emerging Company of 2018" by Economic Times
• Received "Business Excellence Award for 2019" by Economic Times

The corporate structure includes Caplin One Labs Limited (COL), another subsidiary operating an oncology unit in Kakkalur. COL holds 5 approved ANDAs for Injectable and Ophthalmic products and focuses on generic and specialty products for both regulated and other markets.