Sharon Bio-medicine Limited

Sharon Bio-Medicine Limited, established on June 19, 1989, in Panvel, Maharashtra, India, has evolved from a manufacturer of pharmaceutical intermediates and active pharmaceutical ingredients (APIs) to a comprehensive provider of pharmaceutical products and services. The company is listed on the Bombay Stock Exchange under the ticker symbol 532908. Its Corporate Identification Number (CIN) is U24110MH1989PLC052251. The registered office is located at Plot No. L6, Taloja M.I.D.C, Dist Raigad, Navi Mumbai, Maharashtra 410208, India. As of the latest available data, Sharon Bio-Medicine Limited employs approximately 258 professionals. The company's website is www.sharonbio.com.

Sharon Bio-Medicine Limited operates two primary manufacturing facilities:

1. API Manufacturing Facility: Located at Plot No. L-6, M.I.D.C. Taloja, Navi Mumbai, Maharashtra, this facility specializes in the production of pharmaceutical intermediates and APIs. It is cGMP compliant, adhering to national and international standards, and has received approvals from the US FDA, EU GMP, and WHO GMP.

2. Oral Solid Dosage Manufacturing Facility: Situated in Dehradun, India, this facility focuses on the production of oral solid dosage forms, including tablets and capsules. It is approved by the UK MHRA, Health Canada, Invima (Colombia), and has received desktop TGA approval from its customers.

As of June 17, 2025, the key executives at Sharon Bio-Medicine Limited are:

• Purushottam Sharma: Director

• Mukeshkumar Siyaram Singh: Whole-Time Director

• Mahendar Korthiwada: Director

The company's leadership is committed to steering Sharon Bio-Medicine Limited towards its strategic objectives in the pharmaceutical industry.

Sharon Bio-Medicine Limited has established a presence in several regulated markets:

• United States: The company's API manufacturing facility is approved by the US FDA, ensuring compliance with stringent regulatory standards.

• European Union: The same facility holds EU GMP certification, facilitating access to European markets.

• United Kingdom: The oral solid dosage manufacturing facility in Dehradun is approved by the UK MHRA, indicating adherence to UK regulatory requirements.

• Canada: The Dehradun facility also holds approval from Health Canada, expanding its reach in North America.

• Australia: While the Dehradun facility has received desktop TGA approval from its customers, specific TGA certification details are not publicly disclosed.

Sharon Bio-Medicine Limited has made strategic inroads into emerging markets:

• Africa: The company has expanded its market presence across various African countries, leveraging its WHO GMP-certified facilities to meet international standards.

• Latin America: Through approvals such as Invima (Colombia), Sharon Bio-Medicine Limited has established a foothold in Latin American markets, offering a range of pharmaceutical products.

• Southeast Asia: The company's WHO GMP certification and other international approvals have facilitated its entry into Southeast Asian markets, enabling access to a broader customer base.

Sharon Bio-Medicine Limited's geographic strategy demonstrates a balanced approach:

• Diversification: The company has diversified its market presence across regulated markets in North America, Europe, and emerging markets in Africa, Latin America, and Southeast Asia.

• Concentration Risk: While the company has a diversified portfolio, its reliance on specific markets for certain product approvals may pose concentration risks.

• Strategic Direction: Sharon Bio-Medicine Limited continues to focus on expanding its global footprint by obtaining necessary regulatory approvals and certifications to access new markets.

Sharon Bio-Medicine Limited's FDA-related activities include:

• Facility Registration: The API manufacturing facility in Taloja is registered with the US FDA, ensuring compliance with FDA regulations.

• Approved ANDAs: Specific details regarding approved Abbreviated New Drug Applications (ANDAs) are not publicly disclosed.

• DMF Filings: The company has filed Drug Master Files (DMFs) with the FDA, facilitating the approval process for its products.

• Inspection History: There are no publicly available records of FDA inspections or observations for Sharon Bio-Medicine Limited.

Sharon Bio-Medicine Limited holds the following certifications:

• WHO GMP: The API manufacturing facility in Taloja is WHO GMP-certified, indicating compliance with World Health Organization standards.

• EU GMP: The same facility holds EU GMP certification, facilitating access to European markets.

In India, Sharon Bio-Medicine Limited has obtained:

• CDSCO Manufacturing Licenses: The company holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), ensuring compliance with Indian pharmaceutical regulations.

• State Drug Controller Approvals: Specific approvals from state drug controllers are not publicly disclosed.

• Export NOCs: The company has received No Objection Certificates (NOCs) for export from the CDSCO, facilitating international trade.

As of March 28, 2026, there are no publicly available records of recent regulatory actions, such as Form 483 observations, warning letters, or import alerts, against Sharon Bio-Medicine Limited.

Sharon Bio-Medicine Limited operates in a competitive pharmaceutical industry, facing competition from both domestic and international companies. Its focus on high-quality manufacturing and regulatory compliance positions it favorably in the market. However, specific market share comparisons and head-to-head analyses are not publicly available.

Sharon Bio-Medicine Limited's key differentiators include:

• Integrated Services: The company offers a comprehensive range of services, from preclinical toxicology to commercial manufacturing, providing end-to-end solutions for its clients.

• Regulatory Approvals: With certifications from regulatory bodies such as the US FDA, EU GMP, and WHO GMP, Sharon Bio-Medicine Limited demonstrates its commitment to quality and compliance.

Sharon Bio-Medicine Limited's current strategic direction focuses on:

• Generics: The company continues to develop and manufacture generic pharmaceutical products, leveraging its manufacturing capabilities and regulatory approvals.

• Specialty Products: Sharon Bio-Medicine Limited is exploring opportunities in specialty products, aiming to diversify its portfolio and meet specific market needs.

• Biosimilars: There is no publicly available information indicating the company's involvement in biosimilars.

• CDMO: The company offers Contract Development and Manufacturing Organization (CDMO) services, providing contract manufacturing solutions to clients.

Sharon Bio-Medicine Limited's track record includes:

• Export Volume and Consistency: The company has a total export value of $2.1 million USD across 130 shipments, indicating a consistent export performance.

• Reliability Indicators: The company's adherence to international quality standards and regulatory approvals reflects its reliability as a supplier.

Importers should verify the following certifications when considering Sharon Bio-Medicine Limited as a supplier:

• FDA: Verify through the FDA's official website or contact the company directly.

• WHO-GMP: Confirm via the World Health Organization's official website or the company's certifications.

• EU GMP: