Medicamen Biotech Limited

Medicamen Biotech Limited (MBL) is a pharmaceutical company established in December 1993, headquartered in New Delhi, India. The company is publicly listed on the Bombay Stock Exchange (BSE) under the ticker symbol 531146 and on the National Stock Exchange of India (NSE) under the ticker symbol MEDICAMEQ. As of March 12, 2026, MBL's market capitalization was approximately ₹3.54 billion (around $51.65 million USD). The company reported a revenue of ₹1.72 billion (approximately $18.55 million USD) for the trailing twelve months ending December 31, 2025. The Corporate Identification Number (CIN) assigned to MBL is L74899DL1993PLC056594. The company employs approximately 376 individuals. MBL's official website is www.medicamen.com.

MBL operates two primary manufacturing facilities in India:

• Bhiwadi Formulation Plant (Rajasthan): This facility specializes in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. It has received WHO-GMP certification, indicating compliance with international manufacturing standards.

• Haridwar Oncology Plant (Uttarakhand): Dedicated to the production of oncology injectables and oral solid dosages (OSDs), this plant has undergone a comprehensive audit by the US Food and Drug Administration (USFDA) in April 2023, positioning it for potential approvals in regulated markets.

These facilities underscore MBL's commitment to quality manufacturing and regulatory compliance.

The leadership team at Medicamen Biotech Limited includes:

• Rajesh Madan: Chief Executive Officer (CEO)

• Chandan Kumar: Chief Financial Officer (CFO)

• Aneek Gupta: Chief Operating Officer (COO)

• Parul Choudhary: Compliance Officer and Company Secretary

• Ashwani Kumar Sharma: Whole-Time Director

These executives play pivotal roles in steering the company's strategic direction and operations.

Medicamen Biotech Limited has made significant strides in entering regulated markets:

• United States: In July 2023, MBL filed its first Abbreviated New Drug Application (ANDA) for Bortezomib injections with the USFDA, marking a major milestone for the company.

• European Union: In November 2024, the company's Bhiwadi manufacturing facility received EU GMP certification from the National Organisation for Medicines in Athens, Greece, facilitating access to European markets.

• United Kingdom: The Bhiwadi facility's EU GMP certification also aligns with UK regulatory standards, enhancing market access.

• Australia: While specific approvals are not detailed, the EU GMP certification positions MBL favorably for potential market entry.

• Japan: No specific regulatory filings or approvals are reported; however, the company's global certifications may support future market access.

These developments reflect MBL's commitment to expanding its presence in regulated markets.

Medicamen Biotech Limited has been active in emerging markets:

• Africa: The Bhiwadi facility has received global accreditations, including from the National Drug Authority (NDA) of Uganda, facilitating market access.

• Latin America: Accreditations from ANVISA (Brazil) and FM HACA (Ethiopia) support MBL's presence in these regions.

• Southeast Asia: Specific market penetration details are not provided; however, the company's global certifications may enable access.

The WHO prequalification of the Bhiwadi facility further enhances MBL's ability to supply quality medicines to these regions.

Medicamen Biotech Limited's geographic strategy demonstrates a balanced approach:

• Diversification: The company has diversified its manufacturing capabilities across multiple facilities in India, each specializing in different therapeutic areas.

• Concentration Risk: While MBL has a strong presence in India, its expansion into regulated markets like the US and Europe mitigates over-reliance on a single market.

• Strategic Direction: The focus on obtaining international certifications and regulatory approvals indicates a strategic direction towards global market expansion.

This strategy positions MBL to leverage opportunities in both domestic and international markets.

Medicamen Biotech Limited's FDA status includes:

• Facility Registrations: The Haridwar Oncology Plant underwent a comprehensive audit by the USFDA in April 2023, positioning it for potential approvals in regulated markets.

• Approved ANDAs: In July 2023, MBL filed its first ANDA for Bortezomib injections with the USFDA, marking a significant milestone.

• DMF Filings: The company has filed Drug Master Files (DMFs) with the USFDA for its Active Pharmaceutical Ingredients (APIs), demonstrating compliance with FDA standards.

• Inspection History: The Haridwar facility's successful audit in April 2023 indicates a positive inspection history, enhancing the company's credibility.

These factors collectively strengthen MBL's position in the US market.

Medicamen Biotech Limited's compliance with international standards includes:

• WHO Prequalification: The Bhiwadi facility has received WHO-GMP certification, ensuring adherence to global manufacturing practices.

• EU GMP Certificates: The Bhiwadi facility's EU GMP certification from the National Organisation for Medicines in Athens, Greece, facilitates access to European markets.

• EDQM Status: While specific details are not provided, the EU GMP certification aligns with EDQM standards, supporting market access.

These certifications underscore MBL's commitment to quality and regulatory compliance.

Medicamen Biotech Limited's compliance with Indian regulatory standards includes:

• CDSCO Manufacturing Licenses: The company holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) for its facilities.

• State Drug Controller Approvals: MBL's facilities have received approvals from state drug controllers, ensuring adherence to regional regulations.

• Export NOCs: The company has obtained No Objection Certificates (NOCs) for exports, facilitating international trade.

These regulatory compliances affirm MBL's commitment to maintaining high standards in manufacturing and distribution.

Recent regulatory actions involving Medicamen Biotech Limited include:

• Form 483 Observations: Specific details regarding Form 483 observations are not available.

• Warning Letters: No warning letters have been reported.

• Import Alerts: No import alerts have been issued against MBL.

These factors indicate a positive regulatory standing for the company.

In the pharmaceutical industry, Medicamen Biotech Limited faces competition from both domestic and international companies. While specific competitors are not detailed, MBL's focus on quality manufacturing and regulatory compliance positions it favorably in the market. The company's certifications and approvals enhance its competitiveness, enabling it to meet the demands of regulated markets.

Medicamen Biotech Limited's key differentiators include:

• Quality Manufacturing: The company operates state-of-the-art facilities with WHO-GMP and EU GMP certifications, ensuring high-quality products.

• Regulatory Compliance: MBL's successful audits and approvals from agencies like the USFDA