Leben Laboratories Private Limited

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.

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.

The leadership team at Leben Laboratories is headed by Shri Bharat N. Shah, who serves as the Chairman and Managing Director. He holds a Master of Pharmacy and has been instrumental in the company's growth since its inception. Shri Parth B. Shah, the Technical Director, holds a Bachelor of Pharmacy and an MBA, contributing significantly to the company's technical and operational advancements.

Leben Laboratories has established a strong presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facilities are audited and approved by the U.S. Food and Drug Administration (FDA), the World Health Organization's Good Manufacturing Practice (WHO-GMP), and ISO standards. These certifications facilitate the company's access to these markets, ensuring compliance with stringent regulatory requirements.

Leben Laboratories has expanded its reach into emerging markets across Africa, Latin America, and Southeast Asia. The company's products are approved by various national regulatory authorities, including the Afghanistan Food and Drug Authority (AFDA), Nepal's Department of Drug Administration (DDA), Ethiopia's Food and Drug Authority (EFDA), Uganda's National Drug Authority (NDA), Sri Lanka's National Medicines Regulatory Authority (NMRA), Malawi's Pharmacy, Medicines and Regulatory Authority (PMRA), Kenya's Pharmacy and Poisons Board (PPB), Yemen's Supreme Board of Drugs and Medical Appliances (SBDMA), and Zambia's Medicines Regulatory Authority (ZAMRA). These approvals enable Leben Laboratories to distribute its products in these regions, contributing to the company's global footprint.

Leben Laboratories has strategically diversified its geographic presence to mitigate concentration risk. By exporting to over 18 countries, the company has reduced dependency on any single market, thereby enhancing its resilience against regional economic fluctuations. This diversification strategy aligns with the company's goal of achieving sustainable growth and expanding its global footprint.

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.

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.

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.

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.

Leben Laboratories operates in a competitive pharmaceutical market, facing competition from both domestic and international companies. While specific market share data for overlapping categories is not publicly available, the company's diverse product portfolio and international certifications position it favorably in the market. The company's focus on quality manufacturing and regulatory compliance enhances its competitiveness in the global pharmaceutical industry.

Leben Laboratories' key differentiators include its state-of-the-art manufacturing facilities, which are WHO-GMP and EU GMP certified, and its diverse product portfolio spanning multiple therapeutic categories. The company's strategic geographic diversification and adherence to international quality standards further distinguish it in the pharmaceutical industry.

Leben Laboratories' current strategic direction focuses on expanding its presence in both regulated and emerging markets, leveraging its manufacturing capabilities and regulatory approvals. The company's future outlook includes further diversification of its product portfolio and geographic reach, aiming for sustainable growth and enhanced global competitiveness.

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.

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.

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.