Beacon Diagnostics Private Limited

Beacon Diagnostics Private Limited, established on May 15, 1990, is a privately held Indian company specializing in the manufacturing and export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company is registered under the Corporate Identification Number (CIN) U24232GJ1990PTC013764 and is headquartered at 424, New G.I.D.C. Estate, Kabilpore, Navsari, Gujarat, India.

As of the latest available data, Beacon Diagnostics has an authorized capital of ₹25,00,000 and a paid-up capital of ₹9,12,000. The company employs between 501 to 1000 individuals across various functions, including management, manufacturing, quality control, research and development, administration, and logistics.

Beacon Diagnostics operates under the ownership of its promoters, with a significant majority stake held by them. The company's financial performance has shown resilience, with a net worth increase of 20.01% in 2023, despite a minor drop in revenue and a substantial decrease in profitability during the same period.

Beacon Diagnostics boasts a state-of-the-art manufacturing facility spanning over 40,000 square feet in Navsari, Gujarat. This facility is dedicated to the production of diagnostic reagents and medical devices, adhering to stringent quality standards. The plant is equipped with advanced machinery and technology to ensure the efficient and precise manufacturing of its product range.

The leadership team at Beacon Diagnostics is spearheaded by Managing Director Dineshchandra Kalidas Joshi, who has been at the helm since the company's inception in 1990. Other key directors include Swati Narendra Shethji, appointed on June 22, 2006, and Chirag Dineshchandra Joshi, who joined the board on April 7, 2015.

Beacon Diagnostics has made significant strides in expanding its presence in regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has obtained necessary regulatory approvals and certifications, such as ISO 9001:2015 and ISO 13485:2016, which are recognized internationally. These certifications underscore Beacon Diagnostics' commitment to maintaining high-quality standards in its manufacturing processes.

In addition to its presence in regulated markets, Beacon Diagnostics has strategically penetrated emerging markets across Africa, Latin America, and Southeast Asia. The company's adherence to international quality standards, as evidenced by its ISO certifications, facilitates its entry into these regions. While specific details regarding WHO prequalification are not available, the company's global footprint indicates a proactive approach to meeting international regulatory requirements.

Beacon Diagnostics demonstrates a diversified geographic strategy by establishing a presence in both regulated and emerging markets. This approach mitigates concentration risk and positions the company to leverage growth opportunities across different regions. The strategic direction reflects a balanced focus on expanding market reach while maintaining compliance with international standards.

Specific details regarding Beacon Diagnostics' FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly available. However, the company's adherence to ISO 9001:2015 and ISO 13485:2016 certifications suggests a commitment to quality management systems that align with international standards, potentially facilitating FDA compliance.

Beacon Diagnostics holds ISO 9001:2015 and ISO 13485:2016 certifications, which are recognized internationally and align with Good Manufacturing Practice (GMP) standards. While specific WHO prequalification and EU GMP certificates are not explicitly mentioned, the company's commitment to quality is evident through these certifications.

Beacon Diagnostics operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company holds the necessary manufacturing licenses and approvals from state drug controllers, ensuring compliance with Indian pharmaceutical regulations. Additionally, Beacon Diagnostics has obtained the Import Export Code (IEC) 0891003665, facilitating its export activities.

As of the latest available information, there are no publicly disclosed Form 483 observations, warning letters, or import alerts associated with Beacon Diagnostics. The company's adherence to international quality standards and certifications suggests a proactive approach to regulatory compliance.

Beacon Diagnostics operates in a competitive landscape with several key players in the diagnostic reagents and medical devices sector. While specific market share data is not available, the company's extensive product portfolio and international certifications position it favorably in the market. The company's focus on quality and innovation provides a competitive edge in both domestic and international markets.

Beacon Diagnostics' key differentiators include its comprehensive product portfolio, which spans diagnostic reagents and medical devices, and its commitment to quality, as evidenced by ISO 9001:2015 and ISO 13485:2016 certifications. The company's extensive manufacturing facility and dedicated workforce further enhance its ability to meet diverse customer needs.

Beacon Diagnostics is strategically positioned as a manufacturer of diagnostic reagents and medical devices, focusing on both domestic and international markets. The company's adherence to international quality standards and its diversified product portfolio reflect a strategic direction aimed at sustainable growth and market expansion.

Beacon Diagnostics demonstrates a strong track record in manufacturing and exporting diagnostic reagents and medical devices. The company's export volume and consistency are supported by its adherence to international quality standards and certifications. Reliability indicators include its established presence in various international markets and a dedicated workforce committed to quality and customer satisfaction.

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

• ISO 9001:2015: Quality management systems certification. Verification can be done through the International Organization for Standardization (ISO) website.

• ISO 13485:2016: Quality management systems for medical devices certification. Verification can be done through the International Organization for Standardization (ISO) website.

• CE Certification: Indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. Verification can be done through the European Commission's NANDO database.

When engaging with Beacon Diagnostics, importers should consider the following steps:

• Verify Certifications: Confirm the validity of ISO 9001:2015, ISO 13485:2016, and CE certifications through the respective certifying bodies.

• Assess Manufacturing Facilities: Evaluate the scale and capabilities of the manufacturing facility in Navsari, Gujarat.

• Review Regulatory Compliance: Ensure compliance with relevant regulatory bodies, including CDSCO in India and international standards.

• Evaluate Financial Stability: Review the company's financial statements to assess stability and growth trends.

• Check Export Records: Assess the company's export history and consistency in meeting delivery schedules.

Red flags to watch for include discrepancies in certification validity, regulatory non-compliance, financial instability, and inconsistent export performance.