Umedica Laboratories Private Limited

Umedica Laboratories Private Limited, established on January 5, 1982, is a prominent Indian pharmaceutical exporter specializing in the manufacturing and export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company is headquartered in Vapi, Gujarat, India, with its registered office located at P. No-221,222/1, GIDC Vapi, Pardi, Gujarat, 396191.

As a privately held entity, Umedica Laboratories is classified as a non-government company limited by shares. The authorized capital stands at ₹17.50 crore, with a paid-up capital of ₹3.11 crore. The company is part of the Amoli Group of Companies, reflecting a strong foundation in the pharmaceutical industry.

Umedica Laboratories has a significant global presence, exporting to over 85 countries, including the United States, European Union, Canada, Australia, Middle East, Central and South America, Africa, Asia, and CIS countries. The company's diverse product portfolio encompasses antibiotics, anti-diabetics, anti-hyperlipidemics, anti-hypertensives, NSAIDs, analgesics, antifungals, anti-malarials, antihistamines, psychotropics, diuretics, and multivitamins.

Umedica Laboratories operates a state-of-the-art manufacturing facility located in Vapi, Gujarat. This facility is WHO-GMP approved and holds certifications from the US FDA, EU, Health Canada, TGA, and UAE MoH. The plant is equipped with advanced machinery capable of producing a wide range of formulations, including injectables, tablets, capsules, suspensions, and dry syrups.

The manufacturing capabilities are supported by a full-fledged R&D center staffed by a team of qualified and experienced scientists dedicated to improving existing products and developing new formulations. This integration of manufacturing and R&D ensures that Umedica Laboratories maintains high-quality standards and innovation in its product offerings.

The leadership team at Umedica Laboratories is headed by Managing Director Mr. Manish Umed Doshi, who has been instrumental in steering the company since its inception. Other key executives include Ms. Vandana Manish Doshi and Mr. Rupesh Suryakant Kamdar, both serving as directors, contributing to the strategic direction and growth of the company. The company secretary is Ms. Heenal Pankaj Shah, appointed on January 30, 2025, ensuring compliance and efficient corporate governance.

Umedica Laboratories 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 Vapi, Gujarat, is approved by the US FDA, EU, Health Canada, TGA, and UAE MoH, demonstrating compliance with international quality standards. Additionally, Umedica Laboratories has 11 approved ANDAs and 10 different products approved in the EU and UK, reflecting its commitment to meeting stringent regulatory requirements.

The company's adherence to Good Manufacturing Practices (GMP) and other regulatory standards has facilitated its market access in these regions, enabling it to supply a diverse range of pharmaceutical products to meet global healthcare needs.

Umedica Laboratories has expanded its footprint into emerging markets across Africa, Latin America, and Southeast Asia. The company's manufacturing facility has been audited and approved by regulatory authorities in countries such as Zimbabwe, Ethiopia, Tanzania, Nigeria, Uganda, Kenya, Ghana, Ivory Coast, and Malawi. This extensive regulatory compliance facilitates access to these markets, allowing Umedica Laboratories to address the growing demand for quality pharmaceuticals in these regions.

Umedica Laboratories' geographic strategy demonstrates a balanced approach to market diversification. With operations in over 85 countries, the company mitigates concentration risk by not being overly reliant on any single market. This global presence enables Umedica Laboratories to leverage growth opportunities across various regions, including developed markets in the US, EU, and Australia, as well as emerging markets in Africa, Latin America, and Southeast Asia.

The company's strategic direction focuses on expanding its global footprint while maintaining high-quality standards and regulatory compliance, ensuring sustainable growth and resilience in the competitive pharmaceutical industry.

Umedica Laboratories has achieved significant milestones in the US market, with 11 approved Abbreviated New Drug Applications (ANDAs), indicating a robust portfolio of generic drug approvals. The company's manufacturing facility in Vapi, Gujarat, is registered with the US FDA, ensuring compliance with current Good Manufacturing Practices (cGMP). This registration underscores Umedica Laboratories' commitment to maintaining high-quality standards and regulatory compliance in the US market.

The company's adherence to FDA regulations and its established product approvals position it as a reliable supplier of generic pharmaceuticals in the United States.

Umedica Laboratories' manufacturing facility holds WHO-GMP certification, reflecting compliance with international quality standards. Additionally, the facility has been approved by the European Union, Health Canada, TGA, and UAE MoH, demonstrating its commitment to meeting stringent regulatory requirements. These certifications and approvals facilitate Umedica Laboratories' market access in various regions, ensuring the availability of quality pharmaceutical products to meet global healthcare needs.

Umedica Laboratories operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company's manufacturing facility in Vapi, Gujarat, is approved by the CDSCO, ensuring compliance with national quality standards. The facility has also been audited and approved by regulatory authorities in various countries, including the USA, EU, Australia, Canada, and UAE, reflecting its adherence to international quality standards.

These regulatory approvals and licenses enable Umedica Laboratories to manufacture and export pharmaceutical products both domestically and internationally, ensuring the availability of quality medicines to meet diverse healthcare needs.

As of March 28, 2026, there are no publicly available records indicating any Form 483 observations, warning letters, or import alerts issued to Umedica Laboratories by regulatory authorities. The company's manufacturing facility in Vapi, Gujarat, is approved by the US FDA, EU, Health Canada, TGA, and UAE MoH, reflecting compliance with international quality standards. Additionally, the facility has been audited and approved by regulatory authorities in various countries, including the USA, EU, Australia, Canada, and UAE, demonstrating its commitment to maintaining high-quality standards and regulatory compliance.

Umedica Laboratories operates in a competitive pharmaceutical industry, with several key players in the generic drug manufacturing sector. While specific market share data for Umedica Laboratories is not publicly available, the company's extensive product portfolio and global presence position it as a significant competitor in the market. The company's adherence to international quality standards and regulatory compliance further enhance its competitive edge.

Umedica Laboratories' key differentiators include its diverse product portfolio, encompassing antibiotics, anti-diabetics, anti-hyperlipidemics, anti-hypertensives, NSAIDs, analgesics, antifungals, anti-malarials, antihistamines, psychotropics, diuretics, and multivitamins. The company's manufacturing facility in Vapi, Gujarat, is approved by the US FDA, EU, Health Canada, TGA, and UAE MoH, reflecting compliance with international quality standards. Additionally, Umedica Laboratories has 11 approved ANDAs and 10 different products approved in the EU and UK, demonstrating its commitment to meeting stringent regulatory requirements.

Umedica Laboratories' strategic direction focuses on expanding its global footprint while maintaining high-quality