Caplin Steriles Limited Pharmaceutical Export Profile — India (DGFT 2022–2026)

Name: Caplin Steriles Limited Pharmaceutical Export Portfolio Dataset — 4 Products, $16.0M FOB USD, India (DGFT 2022–2026)
Creator: TransData Nexus

Suresh Sormare

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Caplin Steriles Limited — Pharmaceutical Exporter Profile (2026) | 4 Products, $16.0M Trade | TransData Nexus

Caplin Steriles Limited

Indian Pharmaceutical Exporter · Analgesics & Antipyretics Specialist · $16.0M Total Trade · DGFT Verified

Caplin Steriles Limited is an Indian pharmaceutical exporter with a total trade value of $16.0M across 4 products in 3 therapeutic categories. Based on 322 verified export shipments from Indian Customs (DGFT) records, the company actively competes across multiple product segments. Top exports include Ketorolac ($11.5M), Phenylephrine ($3.3M), Verapamil ($1.1M).

Caplin Steriles Limited — Export Portfolio & Destination Treemap

Caplin Steriles Limited pharmaceutical export portfolio — 4 products across 3 therapeutic categories. Source: Indian Customs (DGFT).

Who is Caplin Steriles Limited? — Company Overview & Market Position

Caplin Steriles Limited, established on December 12, 2018, is a public limited company incorporated in Chennai, Tamil Nadu, India. It operates under the Corporate Identification Number (CIN) U24304TN2018PLC126270. The company is a subsidiary of Caplin Point Laboratories Limited, a prominent Indian pharmaceutical firm. Caplin Steriles specializes in the development and manufacturing of high-quality injectable and ophthalmic products tailored for regulated markets. The company's registered office is located at 3rd Floor, Ashvich Towers, No.3, Developed Plots Industrial Estates, Perungudi, Chennai, Tamil Nadu 600096, India.

As of March 2025, Caplin Steriles reported an authorized share capital of ₹190 crore and a paid-up capital of ₹179.96 crore. The company has demonstrated significant growth and expansion since its inception, reflecting its commitment to quality and innovation in the pharmaceutical sector.

What Does Caplin Steriles Limited Export? — Product Portfolio Analysis

Top Products by Export Value

1Ketorolac$11.5M 2

Product Portfolio — Top 4 by Export Value

Caplin Steriles Limited exports 4 pharmaceutical products across 3 therapeutic categories.

#	Product	Category	Export Value	Shipments	Market Share	Rank
1	Ketorolac	Analgesics & Antipyretics	$11.5M	230	9.9%	5
2	Phenylephrine	Respiratory & OTC	$3.3M	65	3.8%	2
3	Verapamil	Cardiovascular	$1.1M	24	1.0%	6
4	Ephedrine	Respiratory & OTC	$150.0K	3	0.7%	7

Caplin Steriles Limited exports 4 pharmaceutical products across 3 therapeutic categories with a total export value of $16.0M. The top category is Analgesics & Antipyretics (71.9% of portfolio), followed by Respiratory & OTC (21.3%), indicating a concentrated portfolio with the top 5 products accounting for 100.0% of total export value.

Caplin Steriles Limited — Corporate Profile & Information

Headquarters, ownership, manufacturing facilities, and key leadership

1Corporate Overview

2Manufacturing Facilities

Caplin Steriles operates a state-of-the-art manufacturing facility located in Gummidipoondi, Tamil Nadu, India. This facility is approved by the US FDA, EU-GMP, INVIMA, and WHO-GMP, underscoring its compliance with international quality standards. The plant specializes in the production of sterile injectables and ophthalmic dosage forms, with a dedicated area for formulation development, analytical development, and stability studies.

The manufacturing capacity is substantial, with current annual outputs of 100 million units for liquid and lyophilized vials, 1 million units for pre-filled syringes, and 1 million units for ophthalmic droppers. Future expansions aim to increase these capacities significantly, including the addition of pre-mix bags and peptide injections.

3Key Leadership

Caplin Steriles Limited is led by a team of experienced professionals committed to the company's growth and adherence to quality standards. The Board of Directors includes:

Mr. C.C. Paarthipan – Chairman
Mr. Partheeban Vivek Siddarth – Director
Mr. Rengaraj Viswanathan – Director
Mr. Prem Venkatachalam Pavoor – Nominee Director
Mr. Komattu Chacko John – Director
Mr. Sathya Narayanan – Chief Financial Officer
Mr. Ketan Mahendra Patel – Nominee Director

These leaders bring a wealth of experience and strategic vision to Caplin Steriles, driving its mission to deliver high-quality pharmaceutical products to regulated markets.

TransData Nexus Research · Government registries, company filings, regulatory databasesMar 2026

Where Does Caplin Steriles Limited Export? — Destination Intelligence

Regulated market presence, emerging market penetration, and geographic strategy

1Regulated Markets

Caplin Steriles has established a strong presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facility in Gummidipoondi has received approvals from the US FDA, EU-GMP, INVIMA, and WHO-GMP, facilitating access to these markets.

In the United States, Caplin Steriles has been proactive in filing Abbreviated New Drug Applications (ANDAs) for its products. For instance, in June 2023, the company received US FDA approval for its ANDA for Cisatracurium Besylate Injection USP, a nondepolarizing skeletal neuromuscular blocker.

The company's commitment to quality and regulatory compliance is further demonstrated by the successful completion of multiple US FDA audits, including an unannounced inspection conducted between August 5th and 9th, 2024, which concluded with zero observations.

2Emerging Markets

Caplin Steriles has strategically expanded its footprint in emerging markets, particularly in Africa, Latin America, and Southeast Asia. The company's manufacturing facility in Suthukeny, Puducherry, India, is approved by INVIMA and WHO-GMP, enabling access to these regions.

The company's focus on emerging markets aligns with its mission to provide high-quality, affordable healthcare solutions to underserved populations. By leveraging its manufacturing capabilities and regulatory approvals, Caplin Steriles is well-positioned to meet the growing demand for pharmaceutical products in these regions.

Caplin Steriles Limited — Manufacturing & Regulatory Profile

FDA status, WHO-GMP certification, EU GMP compliance, and regulatory track record

1FDA Status

Caplin Steriles has demonstrated a strong commitment to meeting the stringent requirements of the US FDA. The company's manufacturing facility in Gummidipoondi, Tamil Nadu, India, has undergone multiple US FDA inspections, including an unannounced inspection conducted between August 5th and 9th, 2024, which concluded with zero observations.

The company has also been proactive in filing ANDAs for its products. In June 2023, Caplin Steriles received US FDA approval for its ANDA for Cisatracurium Besylate Injection USP, a nondepolarizing skeletal neuromuscular blocker.

2WHO & EU GMP

Caplin Steriles' manufacturing facility in Suthukeny, Puducherry, India, holds approvals from WHO-GMP and EU-GMP, reflecting the company's adherence to international quality standards.

These certifications enable Caplin Steriles to supply pharmaceutical products to markets that require compliance with WHO and EU Good Manufacturing Practices, thereby expanding its global reach.

3CDSCO & Indian Regulatory

Caplin Steriles Limited — Competitive Positioning Among Indian Pharma Exporters

Market share comparison, key differentiators, and strategic analysis

1Competitive Landscape

Caplin Steriles operates in a competitive landscape, with several key players in the injectable and ophthalmic pharmaceutical market. The company's focus on high-quality products and adherence to international regulatory standards position it favorably against competitors. However, specific market share comparisons and head-to-head analyses are not available in the provided data.

2Key Differentiators

Caplin Steriles distinguishes itself through its commitment to quality, innovation, and timely availability of medicines. The company's manufacturing facilities are approved by multiple international regulatory bodies, including the US FDA, EU-GMP, INVIMA, and WHO-GMP, facilitating access to a broad range of markets.

Additionally, Caplin Steriles has been proactive in expanding its product portfolio, with plans to launch over 20 products in the next twelve months, demonstrating its dedication to meeting diverse healthcare needs.

3Strategic Position

Caplin Steriles is strategically positioned as an R&D-driven company focusing on the development and manufacturing of high-quality injectables and ophthalmic products for regulated markets. The company's manufacturing facilities are approved by multiple international regulatory bodies, including the US FDA, EU-GMP, INVIMA, and WHO-GMP, facilitating access to a broad range of markets.

Buyer Due Diligence Brief — Evaluating Caplin Steriles Limited as a Supplier

Track record assessment, certifications to verify, and pre-order checks

1Supplier Assessment

Caplin Steriles has demonstrated a strong track record in manufacturing and exporting pharmaceutical products.

TransData Nexus Research · FDA, WHO, EMA regulatory databasesMar 2026

Frequently Asked Questions — Caplin Steriles Limited

How many pharmaceutical products does Caplin Steriles Limited export from India?

Caplin Steriles Limited exports 4 pharmaceutical products across 3 therapeutic categories. The top exports are Ketorolac ($11.5M), Phenylephrine ($3.3M), Verapamil ($1.1M), Ephedrine ($150.0K). Total export value is $16.0M.

What is Caplin Steriles Limited's total pharmaceutical export value?

Caplin Steriles Limited's total pharmaceutical export value is $16.0M, based on 322 verified shipments recorded in Indian Customs (DGFT) data.

What therapeutic categories does Caplin Steriles Limited cover?

Caplin Steriles Limited exports across 3 therapeutic categories. The largest are Analgesics & Antipyretics (71.9%, 1 products), Respiratory & OTC (21.3%, 2 products), Cardiovascular (6.8%, 1 products).

Get Full Caplin Steriles Limited Export Intelligence

Access shipment-level details, pricing data, buyer connections, product breakdown, and competitive analysis. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.

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Official References & Regulatory Resources

Verify manufacturer licensing, GMP certification, and export registration with the agencies above.

Research Methodology & Data Transparency

Suresh Sormare

Verified Author

Pharmaceutical Export-Import Analyst & Trade Intelligence Expert

Suresh Sormare is a pharmaceutical export-import analyst with deep expertise in Indian Customs (DGFT) data, HS code classification, and global pharmaceutical supply chains. His analysis covers 10M+ shipment records across 150+ countries and is used by manufacturers, procurement agencies, and trade consultants worldwide. Suresh specializes in identifying verified suppliers and buyers from customs records, mapping bilateral pharmaceutical trade corridors, analyzing tariff structures and regulatory frameworks across 170+ destination markets, and benchmarking competitive positioning for finished pharmaceutical formulations. His methodology combines granular customs transaction data with regulatory intelligence from FDA, EMA, WHO, CDSCO, and 40+ national drug authorities to deliver actionable trade insights for the pharmaceutical formulations sector.

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Primary Data Source

All trade data is sourced from Indian Customs (DGFT) official shipping bill records — the authoritative government database for India's pharmaceutical trade. Each verified record contains exporter name, consignee (buyer) name, detailed product description, quantity, declared FOB value (USD), port of loading, destination country, and shipment date.

Data Source & Methodology

Trade data sourced from Indian Customs (DGFT) export shipment records. Values represent FOB export value in USD. Market share calculated relative to total Indian pharmaceutical exports per product category. For current shipment-level data, contact TransData Nexus.