Biological E. Limited Pharmaceutical Export Profile — India (DGFT 2022–2026)

Name: Biological E. Limited Pharmaceutical Export Portfolio Dataset — 5 Products, $80.3M FOB USD, India (DGFT 2022–2026)
Creator: TransData Nexus

Suresh Sormare

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Biological E. Limited — Pharmaceutical Exporter Profile (2026) | 5 Products, $80.3M Trade | TransData Nexus

Biological E. Limited

Indian Pharmaceutical Exporter · Other Specialist · $80.3M Total Trade · DGFT Verified

Biological E. Limited is an Indian pharmaceutical exporter with a total trade value of $80.3M across 5 products in 3 therapeutic categories. Based on 1,611 verified export shipments from Indian Customs (DGFT) records, the company actively competes across multiple product segments. Top exports include Vaccine ($60.9M), Enoxaparin ($12.8M), Sodium ($5.0M).

Biological E. Limited — Export Portfolio & Destination Treemap

Biological E. Limited pharmaceutical export portfolio — 5 products across 3 therapeutic categories. Source: Indian Customs (DGFT).

Who is Biological E. Limited? — Company Overview & Market Position

Biological E. Limited (BE) is a privately held Indian biopharmaceutical company established in 1953 by Dr. D.V.K. Raju. Initially incorporated as Biological Products Private Limited, the company began by manufacturing liver extracts and anti-coagulants during India's Swadeshi Movement, a period emphasizing self-reliance in critical healthcare products.

Over the decades, BE has evolved into a globally recognized vaccine manufacturer, supplying over 2 billion doses worldwide. The company's portfolio includes WHO-prequalified vaccines such as the 5-in-1 Pentavalent and Japanese Encephalitis vaccines. BE operates three strategic business units: Branded Formulations, Specialty Generic Injectables, and Vaccines & Biologics.

Headquartered in Hyderabad, Telangana, India, BE employs between 1,000 and 5,000 individuals. The company's corporate identification number (CIN) is U01120TG1953PLC001095. While specific revenue figures are not publicly disclosed, BE's significant presence in the global vaccine market underscores its substantial financial standing.

What Does Biological E. Limited Export? — Product Portfolio Analysis

Top Products by Export Value

1Vaccine$60.9M

Product Portfolio — Top 5 by Export Value

Biological E. Limited exports 5 pharmaceutical products across 3 therapeutic categories.

#	Product	Category	Export Value	Shipments	Market Share	Rank
1	Vaccine	Other	$60.9M	1,218	4.1%	2
2	Enoxaparin	Cardiovascular	$12.8M	255	5.4%	3
3	Sodium	Nutritional Supplements	$5.0M	99	1.4%	15
4	Antitoxin	Other	$1.1M	26	6.0%	4
5	Heparin	Cardiovascular	$650.0K	13	0.2%	13

Biological E. Limited exports 5 pharmaceutical products across 3 therapeutic categories with a total export value of $80.3M. The top category is Other (77.2% of portfolio), followed by Cardiovascular (16.7%), indicating a concentrated portfolio with the top 5 products accounting for 100.0% of total export value.

Biological E. Limited — Corporate Profile & Information

Headquarters, ownership, manufacturing facilities, and key leadership

1Corporate Overview

2Manufacturing Facilities

Biological E. Limited operates state-of-the-art manufacturing facilities in Hyderabad, Telangana, India. These facilities are equipped with advanced technologies to produce a diverse range of pharmaceutical formulations, including vaccines and injectables. The company's manufacturing capabilities are recognized by major regulatory agencies, including the US FDA and the European Medicines Agency (EMA).

3Key Leadership

Mahima Datla serves as the Chief Executive Officer and Managing Director of Biological E. Limited. Under her leadership, the company has expanded its global footprint and enhanced its product portfolio. Other key executives include Ippagunta Yasodhara Rama Krishna Rao and Rudraju Anand Kumar, who contribute to the strategic direction and operational excellence of the organization.

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

Where Does Biological E. Limited Export? — Destination Intelligence

Regulated market presence, emerging market penetration, and geographic strategy

1Regulated Markets

Biological E. Limited has established a significant presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has obtained regulatory approvals from the US FDA and EMA for its vaccines and biologics, facilitating market access in these regions. Additionally, BE's products are listed in the WHO's prequalification program, enabling supply to UN agencies and other international organizations.

2Emerging Markets

Biological E. Limited has expanded its reach into emerging markets across Africa, Latin America, and Southeast Asia. The company's WHO prequalification status has been instrumental in facilitating access to these regions, allowing BE to supply essential vaccines and therapeutics to countries in need.

3Geographic Strategy

Biological E. Limited's geographic strategy demonstrates a balanced approach, with a strong presence in both regulated and emerging markets. The company's WHO prequalification status and regulatory approvals from agencies like the US FDA and EMA have enabled it to mitigate concentration risks and diversify its market presence.

Biological E. Limited — Manufacturing & Regulatory Profile

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

1FDA Status

Biological E. Limited has achieved significant milestones with the US Food and Drug Administration (FDA). The company has received approvals for its vaccines and biologics, facilitating market access in the United States. Additionally, BE's manufacturing facilities are registered with the FDA, ensuring compliance with stringent quality standards.

2WHO & EU GMP

Biological E. Limited's commitment to quality is evidenced by its WHO prequalification status for several vaccines, including the 5-in-1 Pentavalent and Japanese Encephalitis vaccines. This status allows BE to supply vaccines to UN agencies and other international organizations. The company's manufacturing facilities also adhere to European Union Good Manufacturing Practice (EU GMP) standards, ensuring the production of high-quality pharmaceutical products.

3CDSCO & Indian Regulatory

In India, Biological E. Limited holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority. The company complies with state drug controller approvals and has obtained export No Objection Certificates (NOCs), facilitating the export of its pharmaceutical products.

Biological E. Limited — Competitive Positioning Among Indian Pharma Exporters

Market share comparison, key differentiators, and strategic analysis

1Competitive Landscape

Biological E. Limited operates in a competitive landscape alongside other Indian pharmaceutical companies such as Biocon, Bharat Serums and Vaccines Limited, Wockhardt Ltd., and Syngene International Limited. While specific market share data is not publicly disclosed, BE's extensive product portfolio and global reach position it as a significant player in the vaccine and biologics sector.

2Key Differentiators

Biological E. Limited's key differentiators include its extensive experience in vaccine manufacturing, with over 2 billion doses supplied globally, and its WHO prequalification status for multiple vaccines. The company's commitment to quality is further demonstrated by its adherence to international standards such as EU GMP.

3Strategic Position

Biological E. Limited's strategic direction focuses on the development and supply of vaccines and biologics, with a commitment to improving global health. The company's future outlook includes expanding its product portfolio and enhancing its manufacturing capabilities to meet the growing demand for vaccines and therapeutics worldwide.

Buyer Due Diligence Brief — Evaluating Biological E. Limited as a Supplier

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

1Supplier Assessment

Biological E. Limited has a strong track record in the pharmaceutical industry, with a history of supplying over 2 billion doses of vaccines globally. The company's adherence to international quality standards, including WHO prequalification and EU GMP, underscores its reliability as a supplier. Additionally, BE's regulatory approvals from agencies such as the US FDA and EMA further attest to its consistent quality and compliance.

2Certifications to Verify

Importers should verify the following certifications when considering Biological E. Limited as a supplier:

FDA Approval: Confirm the company's products are approved by the US Food and Drug Administration.

WHO-GMP: Ensure the company holds Good Manufacturing Practice certification from the World Health Organization.

EU GMP: Verify adherence to European Union Good Manufacturing Practice standards.

Frequently Asked Questions — Biological E. Limited

How many pharmaceutical products does Biological E. Limited export from India?

Biological E. Limited exports 5 pharmaceutical products across 3 therapeutic categories. The top exports are Vaccine ($60.9M), Enoxaparin ($12.8M), Sodium ($5.0M), Antitoxin ($1.1M), Heparin ($650.0K). Total export value is $80.3M.

What is Biological E. Limited's total pharmaceutical export value?

Biological E. Limited's total pharmaceutical export value is $80.3M, based on 1,611 verified shipments recorded in Indian Customs (DGFT) data.

What therapeutic categories does Biological E. Limited cover?

Biological E. Limited exports across 3 therapeutic categories. The largest are Other (77.2%, 2 products), Cardiovascular (16.7%, 2 products), Nutritional Supplements (6.2%, 1 products).

Get Full Biological E. 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. Profile aggregates 3 company name variants from customs records. For current shipment-level data, contact TransData Nexus.