Alfa Biomed India Private Limited

Alfa Biomed India Private Limited, incorporated on February 10, 2016, is a private limited company based in Pune, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U74999PN2016FTC158316. As of the latest available data, Alfa Biomed India has an authorized capital of ₹68.10 crore and a paid-up capital of ₹27.84 crore. The company is unlisted and operates in the pharmaceutical sector, focusing on the manufacturing of finished pharmaceutical formulations.

The registered office is located at Gat No. 67 and 68, Ahirwade, Naigaon, Old Mumbai-Pune Highway, Village Maval, Pune, Maharashtra, 412106. The company employs approximately 174 professionals as of September 2, 2025.

Alfa Biomed India Private Limited operates manufacturing facilities in Pune, Maharashtra. The plant specializes in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. Specific details regarding production capacities and specialized manufacturing capabilities are not publicly disclosed.

The leadership team of Alfa Biomed India Private Limited includes:

• Aniket Bhalchandra Kulkarni – Additional Director, appointed on December 23, 2024.
• Kiran Sukhdeo Malekar – Director, appointed on January 7, 2021.
• Anushka Abhijit Bora – Additional Director, appointed on December 23, 2024.
• Dinesh Chandak – Director, appointed on August 23, 2021.
• Krishna Abhijit Bora – Additional Director, appointed on December 23, 2024.
• Sahadot Ali Mir – Additional Director, appointed on July 23, 2025.

These appointments reflect the company's commitment to strengthening its leadership team to drive growth and operational excellence.

Alfa Biomed India Private Limited's export activities, as per TransData Nexus proprietary trade data, include shipments totaling $51,000 USD across 35 transactions. The company's product portfolio comprises two products: Pyrantel and Biotin, exported to various international markets. However, specific details regarding regulatory filings, approvals, and market access status in the United States, European Union, United Kingdom, Australia, and Japan are not publicly available. The company's focus on finished pharmaceutical formulations suggests adherence to international quality standards, which is essential for market entry in these regulated regions.

Alfa Biomed India Private Limited's export data indicates a concentration in the Antimalarial & Antiparasitic therapeutic category, accounting for 75.7% of total exports. This focus aligns with the company's potential strategic interest in emerging markets, particularly in regions like Africa and Southeast Asia, where such therapeutic products are in demand. While specific information on WHO prequalification or market penetration in these regions is not available, the company's product portfolio positions it to capitalize on opportunities in these emerging markets.

The company's export data reveals a portfolio concentration, with the top five products accounting for 100% of total exports. This indicates a lack of diversification in its product offerings. Such concentration poses risks, including vulnerability to market fluctuations and regulatory changes affecting these specific products. Strategically, Alfa Biomed India may consider diversifying its product range and exploring new geographic markets to mitigate these risks and enhance growth prospects.

Specific information regarding Alfa Biomed India Private Limited's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history is not publicly available. Given the company's focus on finished pharmaceutical formulations, obtaining FDA approvals would be crucial for market access in the United States. The absence of publicly available data suggests that the company may not yet have established a presence in the U.S. market or is in the early stages of pursuing FDA approvals.

There is no publicly available information confirming whether Alfa Biomed India Private Limited holds WHO prequalification or EU Good Manufacturing Practice (GMP) certificates. Such certifications are essential for market access in various international markets. The company's focus on finished pharmaceutical formulations suggests that obtaining these certifications would be a strategic priority to enhance its global competitiveness.

Alfa Biomed India Private Limited is registered with the Central Drugs Standard Control Organisation (CDSCO) in India, as indicated by its Corporate Identification Number (CIN) U74999PN2016FTC158316. Specific details regarding CDSCO manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not publicly available. The company's compliance with Indian regulatory standards is implied by its active status and operations in the pharmaceutical manufacturing sector.

There are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Alfa Biomed India Private Limited. The absence of such records suggests that the company has maintained a clean regulatory compliance history. However, the lack of publicly available data also indicates limited transparency regarding the company's regulatory interactions.

Alfa Biomed India Private Limited operates in the competitive pharmaceutical manufacturing sector, focusing on finished pharmaceutical formulations. While specific competitors in overlapping categories are not identified, the company's export data indicates a concentration in the Antimalarial & Antiparasitic therapeutic category. This suggests that the company faces competition from other manufacturers specializing in similar therapeutic areas. A detailed market share comparison and head-to-head analysis would require access to proprietary market research data.

Alfa Biomed India Private Limited's focus on finished pharmaceutical formulations, particularly in the Antimalarial & Antiparasitic category, positions it to address specific therapeutic needs. The company's export activities indicate a commitment to international markets, reflecting a strategic approach to global expansion. However, the lack of product diversification and limited publicly available information on regulatory certifications may impact its competitive positioning.

Alfa Biomed India Private Limited's current strategic direction appears to be centered on the manufacturing and export of finished pharmaceutical formulations, with a focus on the Antimalarial & Antiparasitic therapeutic category. The company's export data suggests an interest in international markets, though specific geographic strategies are not detailed. To enhance its strategic position, the company may consider diversifying its product portfolio, obtaining international certifications, and expanding its presence in emerging markets.

Alfa Biomed India Private Limited's export data indicates a total export value of $51,000 USD across 35 shipments, with a portfolio concentration of 100% in its top five products. This suggests a focused approach to its product offerings. The company's compliance with Indian regulatory standards is implied by its active status and operations in the pharmaceutical manufacturing sector. However, the lack of publicly available information on international certifications and regulatory approvals may impact its reliability as a supplier in global markets.

Importers should verify the following certifications before engaging with Alfa Biomed India Private Limited:

• FDA Approval: Confirm that the company's products are approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. Verification can be done through the FDA's official website or by contacting the company directly.

• WHO-GMP Certification: Ensure that the company holds Good Manufacturing Practice (GMP) certification from the World Health Organization (WHO). This can be verified by checking the WHO's official list of prequalified manufacturers or by requesting certification details from the company.

• EU GMP Certification: Verify that the company complies with European Union GMP standards. This can be confirmed by consulting the European Medicines Agency (EMA) or by obtaining certification documents from the company.

• ISO Certification: Check for ISO certifications related to quality management systems (e.g., ISO 9001). Verification can be done by reviewing the company's certification documents or by contacting the certifying body.

Before engaging with Alfa Biomed India Private Limited, importers should undertake the following due diligence steps:

• Verify Regulatory Approvals: Confirm that the company's products are approved by relevant regulatory authorities in target markets.

• Assess Manufacturing Capabilities: Evaluate the company's manufacturing facilities for compliance with international quality standards.

• Review Financial Health: Analyze the company's financial statements to assess stability and profitability.

• Check for Legal Compliance: Ensure that the company adheres to all applicable laws and regulations