M. J. Biopharm Private Limited

M. J. Biopharm Private Limited is a privately held biopharmaceutical company established on June 27, 2002, in Pune, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U24234PN2002PTC158855. As of March 31, 2023, M. J. Biopharm reported an authorized share capital of ₹400 million and a paid-up capital of ₹230.06 million. The company specializes in the manufacture of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections, with a focus on diabetes and endocrine treatments, advanced antibiotics, and advanced diabetes medications.

The company's registered office is located at Plot No. 18, IT Park, Hinjawadi Phase II, Near Emcure Industrial, Pune, Maharashtra, India - 411057. M. J. Biopharm operates manufacturing facilities in Pune and Navi Mumbai, Maharashtra, with a workforce of approximately 524 employees. The company's website is www.mjgroup.co.in.

M. J. Biopharm Private Limited operates manufacturing facilities in Pune and Navi Mumbai, Maharashtra. The Pune facility is situated at Plot No. 18, IT Park, Hinjawadi Phase II, Near Emcure Industrial, Pune, Maharashtra, India - 411057. The Navi Mumbai facility is located in the L-7 M.I.D.C. Industrial Area, Navi Mumbai, Maharashtra, India - 410208. These facilities are equipped to produce a range of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections, with a specialization in diabetes and endocrine treatments, advanced antibiotics, and advanced diabetes medications.

The leadership team at M. J. Biopharm Private Limited includes:

• Amol Jashvant Shah: Managing Director, appointed on July 1, 2020.

• Dhaval Vipin Vashi: Director, appointed on September 27, 2019.

• Kajal Amol Shah: Director, appointed on March 24, 2022.

• Pradakshina Goswami: Company Secretary, appointed on June 9, 2023.

• Pheroze Kersasp Mistry: Nominee Director, appointed on May 4, 2018.

M. J. Biopharm Private Limited has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has obtained regulatory approvals for its finished pharmaceutical formulations, enabling market access in these regions. Specific details regarding regulatory filings, approvals, and market access status are not publicly disclosed. However, the company's focus on high-quality manufacturing practices and adherence to international standards suggest a commitment to meeting the stringent requirements of these markets.

M. J. Biopharm Private Limited has expanded its reach into emerging markets, including Africa, Latin America, and Southeast Asia. The company's adherence to WHO prequalification standards has facilitated access to these regions, allowing it to supply essential medicines to underserved populations. By leveraging its expertise in manufacturing and regulatory compliance, M. J. Biopharm continues to strengthen its presence in these emerging markets, contributing to global health initiatives.

M. J. Biopharm Private Limited's geographic strategy demonstrates a balanced approach to market diversification. While the company has a significant presence in regulated markets such as the United States, European Union, United Kingdom, Australia, and Japan, it has also strategically penetrated emerging markets in Africa, Latin America, and Southeast Asia. This diversification mitigates concentration risk and positions the company to capitalize on growth opportunities across different regions. The strategic direction reflects a commitment to global expansion and the delivery of high-quality pharmaceutical products worldwide.

M. J. Biopharm Private Limited has registered its manufacturing facilities with the U.S. Food and Drug Administration (FDA), ensuring compliance with U.S. regulatory standards. The company has obtained approvals for its Abbreviated New Drug Applications (ANDAs), allowing it to market its generic pharmaceutical products in the United States. Additionally, M. J. Biopharm has filed Drug Master Files (DMFs) with the FDA, providing detailed information about the manufacturing processes and quality controls of its drug substances. The company's facilities have undergone FDA inspections, demonstrating adherence to Good Manufacturing Practices (GMP). These regulatory achievements underscore M. J. Biopharm's commitment to maintaining high-quality standards and meeting the stringent requirements of the U.S. market.

M. J. Biopharm Private Limited has achieved World Health Organization (WHO) prequalification for its manufacturing facilities, indicating compliance with international standards for the production of pharmaceutical products. The company has also obtained European Union Good Manufacturing Practice (EU GMP) certificates, affirming its adherence to EU regulations for pharmaceutical manufacturing. These certifications reflect M. J. Biopharm's dedication to maintaining high-quality manufacturing practices and its capability to supply products to international markets.

M. J. Biopharm Private Limited holds manufacturing licenses issued by the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. The company has obtained approvals from state drug controllers, ensuring compliance with regional regulations. Additionally, M. J. Biopharm has secured export No Objection Certificates (NOCs), facilitating the export of its pharmaceutical products to various international markets. These regulatory approvals demonstrate the company's commitment to maintaining high-quality standards and adhering to both national and international regulatory requirements.

As of March 28, 2026, there have been no publicly reported Form 483 observations, warning letters, or import alerts issued to M. J. Biopharm Private Limited by regulatory authorities. This indicates that the company has maintained a clean regulatory record, reflecting its commitment to compliance with industry standards and regulations.

M. J. Biopharm Private Limited operates in a competitive landscape, with several key players in the pharmaceutical industry offering similar products. The company's focus on high-quality manufacturing, adherence to international regulatory standards, and a diverse product portfolio position it favorably in the market. While specific market share data is not publicly available, M. J. Biopharm's strategic initiatives and commitment to quality suggest a competitive standing within the industry.

M. J. Biopharm Private Limited's key differentiators include its specialization in the production of human insulin, analogue insulin, and GLP-1 agents, both as drug substances and formulations. The company's expertise spans from process development and proof of concept to commercial scale and yield optimization. Additionally, M. J. Biopharm offers contract manufacturing services for various packaging formats, including vials, ampoules, cartridges, and disposable pens. These capabilities enable the company to provide comprehensive solutions to its partners and customers.

M. J. Biopharm Private Limited's current strategic direction focuses on the development and commercialization of generic pharmaceutical products, with a particular emphasis on biosimilars, insulin, and advanced antibiotics. The company's expertise in process development, from proof of concept to commercial scale, positions it to capitalize on opportunities in the generics and biosimilars markets. Looking ahead, M. J. Biopharm aims to expand its product portfolio and strengthen its presence in both regulated and emerging markets, contributing to global health initiatives and enhancing patient access to essential medicines.

M. J. Biopharm Private Limited has demonstrated a strong track record in pharmaceutical manufacturing, with a total export value of $22.4 million USD and 476 shipments across six products in four therapeutic categories from 2022 to 2026. The company's portfolio is highly concentrated, with the top five products accounting for 99.2% of total exports. This concentration indicates a focused approach to product development and market penetration. The company's adherence to international regulatory standards, including WHO prequalification and EU GMP certifications, underscores its reliability as a supplier. M. J. Biopharm's commitment to quality and compliance positions it as a dependable partner in the pharmaceutical industry.

Importers should verify the following certifications when considering M. J. Biopharm Private Limited as a supplier: