Yashraj Biotechnology Limited

Yashraj Biotechnology Limited (YBL) is a public limited company incorporated on May 6, 1999, in Navi Mumbai, Maharashtra, India. The company specializes in the biotechnology sector, focusing on in vitro diagnostics (IVD) and preclinical drug discovery services. YBL is registered under the Corporate Identification Number (CIN) U73100MH1999PLC119769.

The authorized capital of YBL is ₹80 million, with a paid-up capital of ₹49.55 million. As of December 2024, the company employed approximately 275 professionals. The registered office is located at C-232, TTC Industrial Area MIDC, Navi Mumbai, Maharashtra 400705, India. YBL's official website is www.yashraj.com.

YBL operates state-of-the-art manufacturing facilities in Mumbai, India, adhering to ISO 13485 and ISO 9001 standards. These facilities specialize in the production of native and recombinant antigens, monoclonal and polyclonal antibodies, and induced pluripotent stem cells (iPSCs). The company has expanded its global reach by establishing subsidiaries in Germany and the USA to ensure a robust supply chain and exceptional customer service.

The leadership team at YBL comprises individuals with diverse expertise guiding the company's strategic direction. Key executives include:

• Mr. Arvind Bhanushali: Director
• Dr. Haseeb Drabu: Director
• Dr. Subhash Mundra: Director
• Shri. Dinesh Kumar Jain: Managing Director
• Mr. Sanjay Singh: Director
• Dr. Himanshu Mody: Director

These leaders are committed to driving innovation and growth within the company.

YBL's presence in regulated markets such as the United States, European Union, United Kingdom, Australia, and Japan is not explicitly detailed in the available sources. The company's focus on in vitro diagnostics and preclinical drug discovery services suggests potential engagement with these markets. However, specific regulatory filings, approvals, and market access statuses are not provided in the available information.

YBL has expanded its global reach by establishing subsidiaries in Germany and the USA, indicating a strategic focus on emerging markets. The company's expertise in preclinical drug discovery and IVD services positions it to penetrate markets in Africa, Latin America, and Southeast Asia. While specific WHO prequalification status is not mentioned, YBL's commitment to quality and innovation supports its potential for access to these regions.

YBL's geographic strategy includes establishing subsidiaries in Germany and the USA, enhancing its global footprint and supply chain robustness. This diversification reduces concentration risk and aligns with the company's strategic direction to serve a broader international market. The focus on both developed and emerging markets reflects a balanced approach to growth and market penetration.

Specific details regarding YBL's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not available in the provided sources. Given the company's focus on in vitro diagnostics and preclinical drug discovery services, it is plausible that YBL engages with the FDA for relevant approvals. However, without explicit information, a comprehensive assessment cannot be made.

The available information does not specify whether YBL holds WHO prequalification or EU Good Manufacturing Practice (GMP) certificates. The company's adherence to ISO 13485 and ISO 9001 standards indicates a commitment to quality management systems. However, without explicit details on WHO and EU GMP certifications, a definitive assessment cannot be provided.

Specific details regarding YBL's manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), state drug controller approvals, and export No Objection Certificates (NOCs) are not available in the provided sources. Given the company's operations in the biotechnology sector, it is likely that YBL complies with relevant Indian regulatory requirements. However, without explicit information, a comprehensive assessment cannot be made.

The available information does not detail any recent regulatory actions involving YBL, such as Form 483 observations, warning letters, or import alerts. The company's adherence to ISO standards and its global operations suggest a commitment to regulatory compliance. However, without specific data, a definitive assessment cannot be provided.

YBL operates in the competitive biotechnology sector, focusing on in vitro diagnostics and preclinical drug discovery services. While specific competitors are not identified in the available sources, the company's global reach and adherence to quality standards position it favorably in the market. The establishment of subsidiaries in Germany and the USA indicates a strategic approach to competing in international markets.

YBL's key differentiators include its extensive experience in the IVD sector, specializing in native and recombinant antigens, monoclonal and polyclonal antibodies, and iPSCs. The company's commitment to quality is demonstrated by its adherence to ISO 13485 and ISO 9001 standards. The establishment of subsidiaries in Germany and the USA enhances its global presence and supply chain capabilities.

YBL's current strategic direction focuses on in vitro diagnostics and preclinical drug discovery services, with an emphasis on innovation and quality. The company's expansion into stem cell research and the establishment of international subsidiaries reflect a forward-looking approach to growth and market diversification. Future outlooks are not explicitly detailed in the available sources.

YBL's track record in the biotechnology sector is characterized by its specialization in IVD and preclinical drug discovery services. The company's export volume and consistency are not explicitly detailed in the available sources. However, its adherence to international quality standards and the establishment of global subsidiaries suggest reliability and a commitment to meeting customer needs.

Importers should verify the following certifications when considering YBL as a supplier:

• FDA Approval: To ensure compliance with U.S. regulatory standards. Verification can be done through the FDA's official website or by contacting YBL directly.

• WHO-GMP Certification: To confirm adherence to World Health Organization Good Manufacturing Practices. Verification can be done through the WHO's official website or by contacting YBL directly.

• EU GMP Certification: To ensure compliance with European Union Good Manufacturing Practices. Verification can be done through the European Medicines Agency's official website or by contacting YBL directly.

• ISO Certifications: YBL's adherence to ISO 13485 and ISO 9001 standards indicates a commitment to quality management systems. Verification can be done through the International Organization for Standardization's official website or by contacting YBL directly.

When conducting due diligence on YBL, consider the following steps:

• Verify Regulatory Certifications: Confirm the validity of FDA, WHO-GMP, EU GMP, and ISO certifications.

• Assess Financial Stability: Review financial statements and credit reports to evaluate the company's financial health.

• Evaluate Manufacturing Capabilities: Assess the capacity, quality control measures, and compliance of YBL's manufacturing facilities.

• Review Export History: Examine the consistency and volume of YBL's export activities to gauge reliability.

• Conduct Background Checks: Research the company's history, reputation, and any past regulatory issues.

Red flags to watch for include expired or invalid certifications, financial irregularities, quality control issues, and a history of regulatory non-compliance. Recommended pre-order checks involve obtaining and verifying all relevant certifications, reviewing recent financial statements, and conducting site visits to assess manufacturing facilities.