Angel Biogenics Private Limited

Angel Biogenics Private Limited, established on June 26, 2012, is a privately held pharmaceutical company headquartered in Rajkot, Gujarat, India. The company is registered under the Corporate Identification Number (CIN) U24230GJ2012PTC070913. As of the latest available data, Angel Biogenics has an authorized capital of ₹0.25 million and a paid-up capital of ₹0.25 million. The company is unlisted and operates as a non-government entity. Its registered office is located at Office No. 216/217/218 Anmol, Nr. Raj Palace Sadhuvasvani Road, University Road, Rajkot, Gujarat, 360005.

In the fiscal year ending March 31, 2024, Angel Biogenics reported a significant growth trajectory, with a 47.23% increase in total revenue and a 72.51% rise in profit. The company's net worth also saw a substantial increase of 46.59%. The company employs between 26 to 50 people and has an annual turnover ranging from ₹100 million to ₹500 million.

Angel Biogenics operates a manufacturing facility located in Shapar (Veraval), Rajkot, Gujarat. The plant specializes in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The facility is equipped with advanced technology machinery and tools, enabling the company to produce a diverse range of pharmaceutical products.

The leadership team at Angel Biogenics includes:

• Sugamkumar Mansukhlal Sureja: Director, appointed on November 6, 2019.

• Renuka Sugambhai Sureja: Director, appointed on June 26, 2012.

The company's leadership is committed to maintaining high standards in pharmaceutical manufacturing and export.

Angel Biogenics has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company exports a diverse portfolio of finished pharmaceutical formulations, such as insulin, erythromycin, griseofulvin, aminophylline, and benzylpenicillin, across five therapeutic categories. In the fiscal year 2022-2026, the company reported a total export value of $3.4 million USD from 106 shipments. The top five products exported include insulin ($1.7 million, 2.2% market share), erythromycin ($1.2 million, 1.6% market share), griseofulvin ($317,000, 0.9% market share), aminophylline ($86,000, 1.5% market share), and benzylpenicillin ($82,000, 2.1% market share).

Angel Biogenics has expanded its reach to emerging markets in Africa, Latin America, and Southeast Asia. The company's product portfolio includes anticancer agents, antibiotics, anesthetics, antifungals, antidiabetics, and palliative care medications, which are well-suited to meet the healthcare needs of these regions. The company's adherence to international quality standards positions it favorably for market access in these emerging economies.

Angel Biogenics demonstrates a diversified geographic strategy by exporting its products to multiple regions, including North America, Africa, and Southeast Asia. This approach mitigates concentration risk and allows the company to tap into various markets with differing demand dynamics. The strategic direction focuses on expanding the company's global footprint while maintaining a strong presence in existing markets.

As of the latest available data, specific details regarding Angel Biogenics' FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly disclosed. The company continues to focus on enhancing its regulatory compliance to meet the standards of the U.S. Food and Drug Administration.

Angel Biogenics adheres to Good Manufacturing Practices (GMP) as outlined by the World Health Organization (WHO) and the European Union (EU). The company's manufacturing processes are designed to meet international quality standards, ensuring the safety and efficacy of its pharmaceutical products. Specific certifications and prequalification statuses are not publicly disclosed.

Angel Biogenics holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) and has obtained approvals from state drug controllers. The company has also secured export No Objection Certificates (NOCs), facilitating its international trade operations. These regulatory approvals underscore the company's commitment to maintaining high standards in pharmaceutical manufacturing and export.

As of the latest available data, there are no publicly disclosed records of Form 483 observations, warning letters, or import alerts issued to Angel Biogenics by regulatory authorities. The company maintains a proactive approach to regulatory compliance, ensuring adherence to international standards.

In the pharmaceutical export sector, Angel Biogenics faces competition from both domestic and international companies. While specific market share comparisons are not publicly available, the company's focus on a diversified product portfolio and adherence to international quality standards position it competitively in the market. The company's strategic emphasis on emerging markets further enhances its competitive edge.

Angel Biogenics' key differentiators include its diversified product portfolio encompassing anticancer agents, antibiotics, anesthetics, antifungals, antidiabetics, and palliative care medications. The company's commitment to quality, adherence to international manufacturing standards, and strategic focus on emerging markets contribute to its competitive advantages. Additionally, the company's proactive approach to regulatory compliance and market expansion further distinguishes it in the pharmaceutical export sector.

Angel Biogenics is strategically positioned as a manufacturer and exporter of finished pharmaceutical formulations, with a focus on both generic and specialty products. The company's future outlook includes expanding its presence in emerging markets, enhancing its product portfolio, and strengthening its regulatory compliance to meet international standards. This strategic direction aims to drive sustainable growth and establish the company as a reliable partner in the global pharmaceutical industry.

Angel Biogenics has demonstrated a consistent track record in pharmaceutical manufacturing and export, with a total export value of $3.4 million USD from 106 shipments in the fiscal year 2022-2026. The company's product portfolio is diversified across five therapeutic categories, indicating a balanced approach to market demand. The company's adherence to international quality standards and proactive regulatory compliance further enhance its reliability as a supplier.

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

• FDA Facility Registration: Confirm the company's registration status with the U.S. Food and Drug Administration.

• WHO-GMP Certification: Verify adherence to Good Manufacturing Practices as outlined by the World Health Organization.

• EU GMP Certification: Ensure compliance with Good Manufacturing Practices recognized by the European Union.

• ISO Certification: Check for relevant International Organization for Standardization certifications related to quality management systems.

These certifications can typically be verified through the respective regulatory bodies' official websites or by contacting the company directly.

Importers should undertake the following steps to ensure a thorough evaluation of Angel Biogenics:

• Verify Regulatory Approvals: Confirm the company's manufacturing licenses, export NOCs, and compliance with international standards.

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

• Evaluate Product Quality: Request product samples and conduct quality assessments to ensure they meet required standards.

• Review Supply Chain Practices: Examine the company's supply chain management to ensure reliability and efficiency.

• Check References: Obtain feedback from other clients or partners to gauge the company's reputation and reliability.

Red flags to watch for include inconsistent financial records, lack of verifiable certifications, and negative feedback from previous clients. Recommended pre-order checks involve conducting site visits, engaging in direct communication with company representatives, and consulting industry experts for insights.