Delta Biopharma Private Limited

Delta Biopharma Private Limited, incorporated on December 8, 2012, is a privately held pharmaceutical company based in Mumbai, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U24100MH2012PTC238604. Its authorized share capital is ₹50.2 crore, with a paid-up capital of ₹50 crore. The registered office is located at 1017/1018 Corporate Avenue, Sonawala Road, Goregaon East, Mumbai, Maharashtra 400063.

Delta Biopharma specializes in the manufacturing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company has established a significant presence in the global pharmaceutical market, exporting products to over 30 countries. Its product portfolio spans multiple therapeutic categories, with a notable focus on antiviral and HIV medications, antivirals, and diabetes and endocrine treatments.

Delta Biopharma operates manufacturing facilities in Mumbai, Maharashtra, and Tirupati, Andhra Pradesh. The Mumbai facility serves as the company's headquarters and is equipped with state-of-the-art machinery and laboratories for research and development, quality assurance, and quality control. The Tirupati plant, located in Menakuru Village, Naidupeta Mandal, is situated within an industrial park, facilitating efficient production and distribution.

The leadership team at Delta Biopharma includes:

• Rita Khanna: Director since December 8, 2012.
• Chander Mohan Khanna: Director since December 8, 2012.
• Rajat Chander Mohan Khanna: Director since December 8, 2012.
• Rajiv Khanna: Director since March 31, 2015.
• Jyoti Rani: Company Secretary since November 1, 2018.

Delta Biopharma has made significant strides in regulated markets, obtaining approvals from various health authorities. The company holds WHO-GMP certification, enabling it to export products to numerous countries. Additionally, Delta Biopharma has received FSSAI and Schedule M approvals, further solidifying its compliance with international standards.

Delta Biopharma has expanded its reach into emerging markets across Africa, Latin America, and Southeast Asia. The company's WHO-GMP certification facilitates access to these regions, allowing it to meet the growing demand for quality pharmaceutical products. This strategic expansion underscores Delta Biopharma's commitment to global healthcare.

Delta Biopharma's geographic strategy involves a diversified approach, targeting both developed and emerging markets. The company's presence in over 30 countries mitigates concentration risk and demonstrates its adaptability to various regulatory environments. This strategic direction positions Delta Biopharma for sustained growth and market penetration.

As of March 2026, specific details regarding Delta Biopharma's FDA facility registrations, approved ANDAs, DMF filings, and inspection history are not publicly available. The company has not disclosed information about its interactions with the FDA, which may be due to the confidential nature of such regulatory processes.

Delta Biopharma holds WHO-GMP certification, ensuring that its manufacturing processes meet international quality standards. This certification facilitates the company's ability to export products to various countries, including those in the European Union. However, specific details regarding EU GMP certificates and EDQM status are not publicly available.

Delta Biopharma has obtained manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), authorizing it to produce pharmaceutical products for both domestic and international markets. The company complies with Indian regulatory requirements, including approvals from state drug controllers and export No Objection Certificates (NOCs), ensuring adherence to national standards.

As of March 2026, there are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Delta Biopharma by regulatory authorities. The absence of such records suggests that the company maintains a strong compliance track record.

Delta Biopharma operates in a competitive landscape with several key players in the pharmaceutical industry. While specific market share data is not publicly disclosed, the company's focus on antiviral and HIV medications, antivirals, and diabetes and endocrine treatments positions it in direct competition with other pharmaceutical manufacturers specializing in these therapeutic areas. The company's adherence to international quality standards, such as WHO-GMP certification, provides a competitive edge in global markets.

Delta Biopharma's key differentiators include its WHO-GMP certification, enabling exports to over 30 countries, and its comprehensive product portfolio covering primary care, cardiovascular, diabetology, pain management, nephrology, urology, immunology, and nephrology. The company's commitment to quality healthcare and adherence to international standards at every step of the manufacturing process further distinguish it in the pharmaceutical industry.

Delta Biopharma's current strategic direction focuses on manufacturing finished pharmaceutical formulations across various therapeutic areas, including antiviral and HIV medications, antivirals, and diabetes and endocrine treatments. The company's WHO-GMP certification and presence in over 30 countries underscore its commitment to global healthcare. Future outlooks suggest continued expansion into emerging markets and potential diversification into other therapeutic areas to meet global healthcare needs.

Delta Biopharma has demonstrated a consistent track record in pharmaceutical manufacturing, with a total export value of $1.1 million USD across 46 shipments. The company's portfolio includes five products across four therapeutic categories, with a concentration of 100% in its top five products. This indicates a focused approach to product development and market penetration. The company's adherence to international quality standards, such as WHO-GMP certification, and its presence in over 30 countries reflect its reliability and commitment to quality.

Importers should verify the following certifications to ensure product quality and regulatory compliance:

• WHO-GMP Certification: Confirms adherence to international manufacturing standards.
• EU GMP Certificate: Validates compliance with European Union manufacturing standards.
• FDA Approval: Indicates compliance with U.S. Food and Drug Administration regulations.
• ISO Certification: Demonstrates commitment to quality management systems.

These certifications can typically be verified through the issuing authorities' official websites or by requesting copies directly from the manufacturer.

Importers should undertake the following steps to ensure due diligence:

• Verify Certifications: Confirm the validity of WHO-GMP, EU GMP, FDA, and ISO certifications.
• Assess Financial Stability: Review the company's financial statements for profitability and solvency.
• Evaluate Compliance History: Investigate any past regulatory actions or compliance issues.
• Inspect Manufacturing Facilities: Conduct site visits to assess manufacturing practices and quality control measures.
• Review Product Portfolio: Analyze the range and quality of products offered.

Red flags to watch for include expired or invalid certifications, inconsistent financial records, unresolved regulatory issues, and substandard manufacturing practices. Recommended pre-order checks involve obtaining and verifying all relevant certifications, conducting thorough background checks, and ensuring clear communication regarding product specifications and delivery terms.