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.

Caplin Point Laboratories announced that its subsidiary Caplin Steriles Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sodium Phosphates Injection USP. The approval was announced on February 24, 2026, through a press release filed under Regulation 30 with stock exchanges.

Product Specifications and Market Opportunity

The USFDA approval covers Sodium Phosphates Injection USP in three different strengths: 15mM P/5mL, 45mM P/15mL and 150mM P/50mL (3mM P/mL) Single-Dose Vials. This generic product is a therapeutic equivalent version of the Reference Listed Drug from Hospira, Inc., USA.

Medical Applications

Sodium Phosphates Injection is indicated as a source of phosphorus for addition to large volume intravenous fluids, primarily to prevent or correct hypophosphatemia in patients with restricted or no oral intake. The product also serves as an additive for preparing specific parenteral fluid formulas when standard electrolyte or nutrient solutions cannot meet patient needs.

Company Portfolio Expansion

Caplin Steriles Limited has developed and filed 54 ANDAs in the USA independently and with partners, achieving 51 approvals including acquired ANDAs. The subsidiary is currently working on a portfolio of 55+ simple and complex Injectable and Ophthalmic products planned for filing over the next 4 years.