Serum Institute OF India Private Limited Pharmaceutical Export Profile — India (DGFT 2022–2026)

Name: Serum Institute OF India Private Limited Pharmaceutical Export Portfolio Dataset — 2 Products, $162.2M FOB USD, India (DGFT 2022–2026)
Creator: TransData Nexus

Suresh Sormare

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Serum Institute OF India Private Limited — Pharmaceutical Exporter Profile (2026) | 2 Products, $162.2M Trade | TransData Nexus

Serum Institute OF India Private Limited

Indian Pharmaceutical Exporter · Other Specialist · $162.2M Total Trade · DGFT Verified

Serum Institute OF India Private Limited is an Indian pharmaceutical exporter with a total trade value of $162.2M across 2 products in 1 therapeutic categories. Based on 3,287 verified export shipments from Indian Customs (DGFT) records, Serum Institute OF India Private Limited is the #1 Indian exporter in 1 product including Vaccine. Top exports include Vaccine ($161.3M), Antitoxin ($999.9K), .

Serum Institute OF India Private Limited — Export Portfolio & Destination Treemap

Serum Institute OF India Private Limited pharmaceutical export portfolio — 2 products across 1 therapeutic categories. Source: Indian Customs (DGFT).

Who is Serum Institute OF India Private Limited? — Company Overview & Market Position

Serum Institute of India Private Limited (SII), established in 1966 by Cyrus S. Poonawalla, is a leading Indian biotechnology and biopharmaceutical company headquartered in Pune, Maharashtra. The company specializes in the production of vaccines, biopharmaceuticals, and generic drugs, serving a global market. As of the latest available data, SII operates as a private limited company with a Corporate Identification Number (CIN) of U80903PN1984PTC032945. The company's authorized share capital is ₹550,000,000, with a paid-up capital of ₹48,192,530. SII employs a substantial workforce, contributing significantly to the Indian pharmaceutical sector. The official website of Serum Institute of India is www.seruminstitute.com.

What Does Serum Institute OF India Private Limited Export? — Product Portfolio Analysis

Top Products by Export Value

1Vaccine$161.3M 2Antitoxin$999.9K

Product Portfolio — Top 2 by Export Value

Serum Institute OF India Private Limited exports 2 pharmaceutical products across 1 therapeutic categories. Market leader (#1 exporter) in 1 products.

#	Product	Category	Export Value	Shipments	Market Share	Rank
1	Vaccine	Other	$161.3M	3,225	15.5%	1
2	Antitoxin	Other	$999.9K	62	7.5%	3

Serum Institute OF India Private Limited exports 2 pharmaceutical products across 1 therapeutic categories with a total export value of $162.2M. The company is the #1 Indian exporter in 1 product: Vaccine. The top category is Other (100.0% of portfolio), indicating a concentrated portfolio with the top 5 products accounting for 100.0% of total export value.

Serum Institute OF India Private Limited — Corporate Profile & Information

Headquarters, ownership, manufacturing facilities, and key leadership

1Corporate Overview

2Manufacturing Facilities

Serum Institute of India operates multiple manufacturing facilities in Pune, Maharashtra, India. These state-of-the-art plants are equipped with advanced technologies to produce a wide range of vaccines and biopharmaceuticals. The facilities adhere to stringent quality control measures and comply with international standards, ensuring the production of high-quality products. Specific details regarding the capacities and specializations of each plant are proprietary and not publicly disclosed.

3Key Leadership

The leadership of Serum Institute of India is helmed by Cyrus S. Poonawalla, who serves as the Chairman and Managing Director. His son, Adar C. Poonawalla, holds the position of Chief Executive Officer (CEO). Under their guidance, the company has expanded its global footprint and diversified its product portfolio, solidifying its position as a leader in the vaccine manufacturing industry. (craft.co)

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

Where Does Serum Institute OF India Private Limited Export? — Destination Intelligence

Regulated market presence, emerging market penetration, and geographic strategy

1Regulated Markets

Serum Institute of India has established a significant presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has achieved World Health Organization (WHO) prequalification for several of its products, such as the 10-valent pneumococcal conjugate vaccine, Pneumosil, which received prequalification in January 2020. This prequalification facilitates access to international markets and underscores the company's commitment to meeting global health standards. Additionally, SII's products are registered and approved in various countries, enabling the company to supply vaccines to a broad spectrum of markets.

2Emerging Markets

Serum Institute of India has made significant inroads into emerging markets, particularly in Africa, Latin America, and Southeast Asia. The company's WHO prequalification status for products like Pneumosil has been instrumental in facilitating access to these regions. By offering affordable and high-quality vaccines, SII addresses the pressing health needs of these areas, contributing to the global effort in disease prevention and control.

3Geographic Strategy

Serum Institute OF India Private Limited — Manufacturing & Regulatory Profile

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

1FDA Status

Serum Institute of India has registered its manufacturing facility with the U.S. Food and Drug Administration (FDA), indicating compliance with U.S. regulatory standards. The facility has undergone multiple FDA inspections, with some resulting in observations. However, specific details regarding the nature of these observations and subsequent corrective actions are not publicly disclosed. The company's commitment to adhering to FDA regulations underscores its dedication to maintaining high-quality manufacturing practices.

2WHO & EU GMP

Serum Institute of India has achieved World Health Organization (WHO) prequalification for several of its products, including Pneumosil, a 10-valent pneumococcal conjugate vaccine. This prequalification, granted in January 2020, signifies that the product meets international standards for quality, safety, and efficacy. Additionally, SII's manufacturing facilities comply with European Union Good Manufacturing Practice (EU GMP) standards, ensuring that products meet the stringent requirements of the European market.

3CDSCO & Indian Regulatory

Serum Institute OF India Private Limited — Competitive Positioning Among Indian Pharma Exporters

Market share comparison, key differentiators, and strategic analysis

1Competitive Landscape

Serum Institute of India operates in a competitive landscape with several key players in the vaccine manufacturing industry. Top competitors include multinational corporations such as Pfizer, Merck, and GlaxoSmithKline, as well as other Indian manufacturers like Bharat Biotech and Biological E. SII distinguishes itself through its extensive product portfolio, including vaccines for diseases like polio, hepatitis B, and COVID-19, and its commitment to affordability and accessibility. The company's focus on large-scale production and global distribution further strengthens its competitive position. (give.do)

2Key Differentiators

Serum Institute of India's key differentiators include its status as the world's largest vaccine manufacturer by volume, producing over 1.5 billion doses annually. (give.do) The company's commitment to affordability ensures that life-saving vaccines are accessible to underprivileged populations globally. Additionally, SII's extensive experience in vaccine development and manufacturing, coupled with its robust regulatory compliance, positions it as a leader in the biopharmaceutical industry.

3Strategic Position

Buyer Due Diligence Brief — Evaluating Serum Institute OF India Private Limited as a Supplier

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

1Supplier Assessment

Serum Institute of India has a strong track record in the pharmaceutical industry, with a substantial export volume and consistency in product quality. The company's adherence to international regulatory standards and its commitment to affordability and accessibility make it a reliable supplier for global markets. Indicators of reliability include its WHO prequalification status and compliance with EU GMP standards, reflecting the company's dedication to maintaining high-quality manufacturing practices.

2Certifications to Verify

Importers should verify the following certifications when considering Serum Institute of India as a supplier:

FDA Facility Registration: Confirm the registration of SII's manufacturing facility with the U.S. Food and Drug Administration (FDA) to ensure compliance with U.S. regulatory standards.

WHO Prequalification: Verify the prequalification status of SII's products with the World Health Organization (WHO) to ensure they meet international standards for quality, safety, and efficacy.

Frequently Asked Questions — Serum Institute OF India Private Limited

How many pharmaceutical products does Serum Institute OF India Private Limited export from India?

Serum Institute OF India Private Limited exports 2 pharmaceutical products across 1 therapeutic categories. The top exports are Vaccine ($161.3M), Antitoxin ($999.9K). Total export value is $162.2M.

What is Serum Institute OF India Private Limited's total pharmaceutical export value?

Serum Institute OF India Private Limited's total pharmaceutical export value is $162.2M, based on 3,287 verified shipments recorded in Indian Customs (DGFT) data.

In which products is Serum Institute OF India Private Limited the #1 Indian exporter?

Serum Institute OF India Private Limited is the #1 Indian exporter in 1 products: Vaccine (15.5% market share).

What therapeutic categories does Serum Institute OF India Private Limited cover?

Serum Institute OF India Private Limited exports across 1 therapeutic categories. The largest are Other (100.0%, 2 products).

Get Full Serum Institute OF India Private 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.