Gufic Biosciences Limited

Gufic Biosciences Limited, established in 1970, is a prominent Indian pharmaceutical company specializing in the manufacturing and marketing of active pharmaceutical ingredients (APIs), generic formulations, and lyophilized injectable products. Incorporated as a public company on December 23, 1984, it is headquartered in Mumbai, Maharashtra, India. The company is listed on both the National Stock Exchange (NSE) under the ticker symbol GUFICBIO and the Bombay Stock Exchange (BSE) with the code 509079.

Gufic Biosciences operates with a promoter holding of 92.83% and a public holding of 4.10%, reflecting a strong promoter commitment. The company's Corporate Identification Number (CIN) is L24100MH1984PLC033519. As of the latest available data, Gufic Biosciences employs approximately 1,484 individuals. The company's official website is gufic.com.

Gufic Biosciences operates multiple manufacturing facilities across India, specializing in the production of lyophilized injections, active pharmaceutical ingredients (APIs), and herbal formulations. The company boasts a fully automated lyophilization plant, which is among the largest in India, enabling the production of a diverse range of products, including antibiotics, antifungals, cardiac medications, infertility treatments, antiviral solutions, and proton pump inhibitors.

Additionally, Gufic Biosciences has WHO-GMP compliant manufacturing plants for injectables and herbal products, as well as an API manufacturing plant catering to regulated markets. These facilities underscore the company's commitment to quality and regulatory compliance in its manufacturing processes.

The leadership team at Gufic Biosciences Limited is headed by:

• Jayesh Pannalal Choksi: Chairman and Managing Director
• Pranav Jayesh Choksi: Chief Executive Officer and Whole-Time Director
• Pankaj Jayakumar Gandhi: Whole-Time Director
• Devkinandan B. Roonghta: Chief Financial Officer
• Nagesh Yarrabathina: Chief Operating Officer
• Avik Das: Investor Relations Officer
• Ami Naresh Shah: Senior Manager of Legal, Company Secretary, and Compliance Officer
• Pinak Padhya: Associate Vice President - Sales and Marketing
• Sunil Desai: Head of Human Resource Department
• Ashok Laxman Dev: President of Operations

This team brings a wealth of experience and expertise to the company's strategic and operational initiatives.

Gufic Biosciences Limited has established a significant presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has filed multiple Drug Master Files (DMFs) with the U.S. Food and Drug Administration (FDA), facilitating the marketing of its products in the U.S. In Europe, Gufic has registered numerous Active Pharmaceutical Ingredients (APIs) and holds certifications from the European Medicines Agency (EMA), ensuring compliance with stringent European standards.

In the United Kingdom, Gufic's products are authorized by the Medicines and Healthcare products Regulatory Agency (MHRA), reflecting the company's adherence to UK regulatory requirements. The company also holds certifications from the Therapeutic Goods Administration (TGA) in Australia and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, demonstrating its commitment to meeting international quality and safety standards.

Gufic Biosciences Limited has strategically expanded its footprint into emerging markets across Africa, Latin America, and Southeast Asia. The company's adherence to World Health Organization (WHO) Good Manufacturing Practices (GMP) and prequalification processes has been instrumental in facilitating market access in these regions. By obtaining WHO prequalification, Gufic ensures that its products meet international quality standards, thereby enhancing their acceptance in these emerging markets.

Gufic Biosciences Limited has adopted a diversified geographic strategy, establishing a presence in both developed and emerging markets. This approach mitigates concentration risk and leverages growth opportunities across different regions. The company's strategic direction focuses on expanding its global footprint while maintaining a strong base in India, thereby balancing risk and capitalizing on diverse market dynamics.

Gufic Biosciences Limited has registered multiple facilities with the U.S. Food and Drug Administration (FDA), enabling the export of its pharmaceutical products to the United States. The company has filed several Abbreviated New Drug Applications (ANDAs), facilitating the marketing of its generic formulations in the U.S. market. Additionally, Gufic has submitted numerous Drug Master Files (DMFs) to the FDA, providing detailed information about the manufacturing processes and quality controls of its products. The company's facilities have undergone FDA inspections, and there are no records of Form 483 observations, warning letters, or import alerts, indicating a strong compliance history.

Gufic Biosciences Limited's manufacturing facilities are compliant with World Health Organization (WHO) Good Manufacturing Practices (GMP), ensuring that its products meet international quality standards. The company holds EU GMP certificates, demonstrating its adherence to European manufacturing standards. These certifications are crucial for accessing and maintaining a presence in regulated markets worldwide.

In India, Gufic Biosciences Limited operates under the regulations of the Central Drugs Standard Control Organisation (CDSCO). The company holds manufacturing licenses from CDSCO, authorizing the production of pharmaceutical products for both domestic and export markets. Gufic has obtained approvals from various state drug controllers, facilitating the distribution of its products across different states in India. The company also possesses export No Objection Certificates (NOCs), enabling the export of its products to international markets.

As of the latest available information, there are no records of Form 483 observations, warning letters, or import alerts issued by the U.S. Food and Drug Administration (FDA) against Gufic Biosciences Limited. This indicates a strong compliance history and adherence to regulatory standards. Similarly, there are no reported regulatory actions from other authorities such as the European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), or the Central Drugs Standard Control Organisation (CDSCO) against the company.

Gufic Biosciences Limited operates in a competitive landscape with several key players in the pharmaceutical industry. In the lyophilized injectable segment, the company faces competition from both domestic and international manufacturers. While specific market share data is not available, Gufic's focus on specialized medicinal segments and its commitment to quality and innovation provide a competitive edge. The company's diversified product portfolio, including APIs, generic formulations, and herbal products, further strengthens its position in the market.

Gufic Biosciences Limited's key differentiators include its specialization in lyophilized products, which are critical for certain medications requiring stability and efficacy. The company's fully automated lyophilization plant enhances production efficiency and product quality. Additionally, Gufic's strong emphasis on research and development drives innovation, enabling the company to introduce new products and improve existing formulations. The company's adherence to international quality standards, as evidenced by its WHO-GMP and EU-GMP certifications, further distinguishes it in the global market.

Gufic Biosciences Limited's current strategic direction focuses on expanding its global footprint while maintaining a strong base in India. The company's emphasis on specialized medicinal segments, such as lyophilized products, critical care medicines, and infertility treatments, positions it well in both domestic and international markets. Looking ahead, Gufic aims to leverage its manufacturing capabilities and regulatory approvals to explore opportunities in generics, specialty pharmaceuticals, and contract manufacturing. The company's commitment to innovation and quality positions it for sustained growth