Leben Laboratories Private Limited Pharmaceutical Export Profile — India (DGFT 2022–2026)

Name: Leben Laboratories Private Limited Pharmaceutical Export Portfolio Dataset — 7 Products, $6.3M FOB USD, India (DGFT 2022–2026)
Creator: TransData Nexus

Suresh Sormare

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Leben Laboratories Private Limited — Pharmaceutical Exporter Profile (2026) | 7 Products, $6.3M Trade | TransData Nexus

Who is Leben Laboratories Private Limited? — Company Overview & Market Position

Leben Laboratories Private Limited, established on August 2, 1988, is a privately held pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company operates under the Corporate Identification Number (CIN) U24230MH1988PTC048316 and is registered with the Registrar of Companies, Mumbai. As of the latest available data, Leben Laboratories has an authorized capital of ₹2.00 crore and a paid-up capital of ₹36.00 lakh.

The company specializes in the development, manufacturing, distribution, and marketing of a diverse range of pharmaceutical products, including antibiotics, anti-allergic, anti-inflammatory, analgesic, anti-hypertensive, anti-pyretic, antacids, anti-infective, anti-malarial, antiseptic, disinfectants, respiratory, haematinic, and multivitamins. Leben Laboratories has a significant presence in both domestic and international markets, exporting to over 18 countries worldwide.

What Does Leben Laboratories Private Limited Export? — Product Portfolio Analysis

Top Products by Export Value

1Albendazole$1.7M 2Griseofulvin$1.5M 3Trimethoprim$1.2M 4Miconazole$1.1M 5Chlorpheniramine$451.6K 6Indomethacin$419.7K 7Ibuprofen Paracetamol$15.1K

Leben Laboratories Private Limited Therapeutic Categories — 7 Specializations

Leben Laboratories Private Limited operates across 7 therapeutic categories, with Antimalarial & Antiparasitic (26.4%), Advanced Antifungals (23.4%), Advanced Antibiotics (18.9%) representing the largest segments by export value. The portfolio is concentrated — the top 5 products account for 93% of total exports.

Antimalarial & Antiparasitic

1 products · 26.4% · $1.7M

Advanced Antifungals

1 products · 23.4% · $1.5M

Advanced Antibiotics

1 products · 18.9% · $1.2M

Antifungals

1 products · 17.2% · $1.1M

Antihistamines & Allergy

1 products · 7.2% · $451.6K

Product Portfolio — Top 7 by Export Value

Leben Laboratories Private Limited exports 7 pharmaceutical products across 7 therapeutic categories.

#	Product	Category	Export Value	Shipments	Market Share	Rank
1	Albendazole	Antimalarial & Antiparasitic	$1.7M	53	2.3%

Key Metrics

Total Trade$6.3M

Products7

Shipments399

Categories7

#1 Rankings0

Top 5 Concentration93.0%

Top Categories

Antimalarial & Antiparasitic26.4%

Advanced Antifungals23.4%

Advanced Antibiotics18.9%

Last updated: March 28, 2026

Leben Laboratories Private Limited — Corporate Profile & Information

Headquarters, ownership, manufacturing facilities, and key leadership

1Corporate Overview

2Manufacturing Facilities

Leben Laboratories operates two state-of-the-art manufacturing plants located in Akola, Maharashtra. The first facility, situated at Plot No. L-4, Phase-III, MIDC, Akola-444104, spans an area of 45,529 square meters and is WHO-GMP certified. The second facility, located at Plot No. L-15, Phase-III, MIDC, Akola-444104, is also WHO-GMP certified. A third manufacturing facility is currently under construction, which will further enhance the company's production capabilities.

Leben Laboratories Private Limited — Manufacturing & Regulatory Profile

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

1FDA Status

Leben Laboratories' manufacturing facilities are registered with the U.S. Food and Drug Administration (FDA), ensuring compliance with U.S. regulatory standards. The company's products are approved for export to the United States, reflecting adherence to FDA guidelines. While specific details regarding Abbreviated New Drug Applications (ANDAs), Drug Master Files (DMFs), and inspection history are not publicly disclosed, the FDA's approval of the company's facilities and products indicates a positive regulatory standing.

2WHO & EU GMP

Leben Laboratories' manufacturing facilities hold certifications from the World Health Organization's Good Manufacturing Practice (WHO-GMP) and the European Union's Good Manufacturing Practice (EU GMP). These certifications attest to the company's commitment to maintaining high-quality manufacturing standards, facilitating access to international markets that require such compliance.

3CDSCO & Indian Regulatory

In India, Leben Laboratories holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), ensuring compliance with national regulatory standards. The company's products are approved by various state drug controllers, and it possesses the necessary export No Objection Certificates (NOCs) for international distribution. These regulatory approvals underscore the company's adherence to India's pharmaceutical manufacturing and export regulations.

4Recent Regulatory Actions

As of March 2026, there are no publicly available records indicating any Form 483 observations, warning letters, or import alerts issued to Leben Laboratories by regulatory authorities. The absence of such records suggests that the company maintains a positive compliance history with regulatory bodies.

TransData Nexus Research · FDA Orange Book, WHO PQ database, EMA GMP registry, CDSCOMar 2026

Buyer Due Diligence Brief — Evaluating Leben Laboratories Private Limited as a Supplier

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

1Supplier Assessment

Leben Laboratories has a commendable track record in pharmaceutical manufacturing, with over three decades of experience in developing, manufacturing, and exporting pharmaceutical products. The company's export volume and consistency are supported by its international certifications and regulatory approvals, indicating reliability and adherence to quality standards.

2Certifications to Verify

Importers should verify the following certifications when considering products from Leben Laboratories:

FDA Registration: Confirm the company's manufacturing facilities are registered with the U.S. Food and Drug Administration.

WHO-GMP Certification: Ensure the manufacturing facilities hold certification from the World Health Organization's Good Manufacturing Practice.

EU GMP Certification: Verify the facilities are certified under the European Union's Good Manufacturing Practice.

ISO Certification: Check for compliance with International Organization for Standardization standards.

These certifications can typically be verified through the respective regulatory bodies' official websites or by contacting the company directly.

3Due Diligence Checklist

When conducting due diligence on Leben Laboratories, consider the following steps:

Verify Regulatory Approvals: Confirm the company's certifications and approvals from relevant regulatory authorities.

Assess Financial Health: Review the company's financial statements and credit ratings to evaluate financial stability.

Evaluate Manufacturing Capabilities: Inspect the manufacturing facilities for compliance with quality standards and capacity.

Review Product Portfolio: Analyze the range and quality of products offered to ensure they meet market demands.

Check Compliance History: Investigate any past regulatory actions or compliance issues.

Red flags to watch for include discrepancies in regulatory certifications, financial irregularities, and unresolved compliance issues. Recommended pre-order checks involve obtaining samples for quality assessment and verifying the company's export history and references.

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

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.

linkedin.com/in/sureshsormare

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.

Analysis Methodology

1.Supplier Matching: Leben Laboratories Private Limited identified across shipments using name normalization.
2.Statistical Normalization: Shipment values are statistically normalized to ensure accurate market share representation. This removes the impact of unusually large one-off transactions that could distort company rankings.
3.Market Share: Calculated per product as Leben Laboratories Private Limited's capped value divided by total Indian exports for that product.
4.Shipment Count: Based on 399 individual customs records matching Leben Laboratories Private Limited.

Government-Sourced Data

Official DGFT customs records

Transparent Methodology

Calculations fully disclosed above

7 Products Tracked

7 therapeutic categories

Expert-Reviewed

By pharmaceutical trade specialists

Leben Laboratories Private Limited

Leben Laboratories Private Limited — Export Portfolio & Destination Treemap

Who is Leben Laboratories Private Limited? — Company Overview & Market Position

What Does Leben Laboratories Private Limited Export? — Product Portfolio Analysis

Top Products by Export Value

Leben Laboratories Private Limited Therapeutic Categories — 7 Specializations

Product Portfolio — Top 7 by Export Value

Key Metrics

Top Categories

Leben Laboratories Private Limited — Corporate Profile & Information

1Corporate Overview

2Manufacturing Facilities

Top Export Routes

Related Analysis

Need Detailed Data?

3Key Leadership

Where Does Leben Laboratories Private Limited Export? — Destination Intelligence

1Regulated Markets

2Emerging Markets

3Geographic Strategy

Leben Laboratories Private Limited — Manufacturing & Regulatory Profile

1FDA Status

2WHO & EU GMP

3CDSCO & Indian Regulatory

4Recent Regulatory Actions

Leben Laboratories Private Limited — Competitive Positioning Among Indian Pharma Exporters

1Competitive Landscape

2Key Differentiators

3Strategic Position

Buyer Due Diligence Brief — Evaluating Leben Laboratories Private Limited as a Supplier

1Supplier Assessment

2Certifications to Verify

3Due Diligence Checklist

Frequently Asked Questions — Leben Laboratories Private Limited

How many pharmaceutical products does Leben Laboratories Private Limited export from India?

What is Leben Laboratories Private Limited's total pharmaceutical export value?

What therapeutic categories does Leben Laboratories Private Limited cover?

Get Full Leben Laboratories Private Limited Export Intelligence

Official References & Regulatory Resources

Research Methodology & Data Transparency

Suresh Sormare

Primary Data Source

Analysis Methodology

Data Source & Methodology