Afrinext Overseas Private Limited

Afrinext Overseas Private Limited, established on April 13, 2017, is a private limited company headquartered in Vadodara, Gujarat, India. The company is registered under the Corporate Identification Number (CIN) U74999GJ2017PTC096837 and is classified as a non-government entity. With an authorized and paid-up capital of ₹1.00 million, Afrinext has demonstrated consistent growth in the pharmaceutical export sector. As of the financial year ending March 31, 2024, the company reported a 27.98% increase in total revenue and a 41.41% rise in profit, reflecting its expanding market presence.

The company's product portfolio includes tablets, capsules, liquid orals, dry syrups, dry injections, β-lactam syrups, liquid injections, surgical products, lozenges, nasal drops, eye and ear preparations, creams, ointments, and medical devices. Afrinext has been recognized as a Star Export House by the Government of India, underscoring its significant contribution to the country's export sector.

Afrinext operates three WHO-GMP approved manufacturing facilities, each specializing in distinct product categories:

• Plant 1: Focuses on general tablets, capsules, creams, and ointments.
• Plant 2: Specializes in liquid orals.
• Plant 3: Dedicated to β-lactam products, including tablets, capsules, and dry powder for suspension.

Strategically located near ports and airports, these facilities ensure efficient and timely delivery of products to global markets.

Afrinext is led by two directors:

• Hitesh Lalwani: Serving as a director since April 13, 2017.
• Nidhi Lalwani Hitesh: Also a director since April 13, 2017.

Both directors have been instrumental in steering the company towards its current growth trajectory.

Afrinext's export data indicates a focus on markets in Africa, with shipments to countries such as Uganda, Cameroon, and Kenya. The company's adherence to WHO-GMP standards enhances its credibility in these regions, facilitating smoother market access.

Afrinext's strategic focus on African markets, including Uganda, Cameroon, and Kenya, aligns with its goal to expand its global footprint. The company's compliance with WHO-GMP standards positions it favorably for market access in these regions.

Afrinext's export data reveals a concentration in African markets, particularly Uganda, Cameroon, and Kenya. This focus suggests a strategic emphasis on these regions, potentially exposing the company to market-specific risks. Diversifying its geographic presence could mitigate such risks and enhance overall stability.

Specific details regarding Afrinext's FDA facility registrations, approved ANDAs, DMF filings, and inspection history are not publicly available. The company's adherence to WHO-GMP standards suggests a commitment to quality, which is essential for FDA approvals.

Afrinext's manufacturing facilities are WHO-GMP approved, indicating compliance with international quality standards. However, there is no publicly available information regarding EU GMP certification or EDQM status.

Afrinext holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), ensuring compliance with Indian regulatory standards. The company's export data reflects adherence to national and international quality requirements, as evidenced by its Star Export House recognition.

There are no publicly available records of Form 483 observations, warning letters, or import alerts associated with Afrinext. The company's adherence to WHO-GMP standards and its Star Export House recognition suggest a strong compliance record.

Afrinext operates in a competitive pharmaceutical export market, with key competitors likely including other Indian pharmaceutical exporters. While specific market share data is not available, Afrinext's focus on high-quality products and adherence to international standards position it favorably in the market.

Afrinext's commitment to quality is demonstrated through its WHO-GMP approved manufacturing facilities and its Star Export House recognition. The company's diverse product portfolio and strategic focus on African markets further distinguish it in the pharmaceutical export sector.

Afrinext's current strategic direction emphasizes the export of finished pharmaceutical formulations, particularly targeting African markets. The company's adherence to international quality standards and its Star Export House recognition support this strategy. Future growth may involve diversifying its product offerings and expanding into additional international markets.

Afrinext's export data indicates a consistent volume of shipments, primarily to African markets. The company's adherence to WHO-GMP standards and its Star Export House recognition suggest reliability and a strong track record in the pharmaceutical export sector.

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

• WHO-GMP Certification: Confirm the validity of Afrinext's WHO-GMP certification by contacting the World Health Organization or reviewing the certificate directly.
• EU GMP Certification: If applicable, verify EU GMP certification through the European Medicines Agency or the company's official documentation.
• FDA Registration: Check the FDA's database for Afrinext's facility registrations and approved products.
• ISO Certifications: Review Afrinext's ISO certifications to assess quality management systems.

Importers should undertake the following steps to ensure a reliable partnership with Afrinext:

• Verify Certifications: Confirm the validity of WHO-GMP, EU GMP, FDA, and ISO certifications.
• Assess Financial Health: Review Afrinext's financial statements for the latest fiscal year to evaluate profitability and financial stability.
• Evaluate Compliance Records: Investigate any regulatory actions or compliance issues associated with Afrinext.
• Inspect Manufacturing Facilities: If possible, conduct site visits to assess manufacturing practices and quality control measures.
• Review Product Portfolio: Analyze Afrinext's product offerings to ensure they meet your market requirements.

By following this checklist, importers can make informed decisions and establish a trustworthy business relationship with Afrinext Overseas Private Limited.