Zenex Animal Health India Private Limited

Zenex Animal Health India Private Limited, incorporated on March 9, 2021, is a private company headquartered in Ahmedabad, Gujarat, India. The company is registered with the Corporate Identification Number (CIN) U24299GJ2021PTC120998. As of March 2026, Zenex has an authorized share capital of ₹3,000 crore and a paid-up capital of ₹2,513.10 crore. The company specializes in the manufacture of animal health products, focusing on both allopathic and herbal formulations for livestock, poultry, and companion animals.

In 2023, Zenex reported net sales of ₹7,490.62 million and a total income of ₹7,537.94 million. The company's EBITDA stood at ₹1,782.32 million, with a margin of 23.64%, and a profit after tax (PAT) of ₹193.06 million, reflecting a PAT margin of 2.56%. As of April 9, 2024, Zenex employed 831 individuals, indicating a growing workforce in line with its expanding operations.

Zenex operates two state-of-the-art manufacturing facilities in India:

1. Haridwar, Uttarakhand: This plant specializes in pharmaceutical formulations, including injectables, oral liquids, powders, tablets, and boluses. It holds WHO-GMP certification and international regulatory approvals, ensuring high-quality production standards.

2. Baddi, Himachal Pradesh: Focusing on herbal feed supplements and Ayurvedic veterinary products, this facility caters to the growing demand for natural solutions in animal healthcare. It is ISO 9001-2015 certified, with a DSIR-approved R&D facility and an AYUSH-certified Quality Control Lab, underscoring its commitment to quality and innovation.

Zenex is led by a team of seasoned professionals:

• Renuka Ramnath: Chairperson of Zenex Animal Health India Pvt Ltd, Renuka is also the Founder, Managing Director, and CEO of Multiples Alternate Asset Management Private Limited. With over 35 years in financial services, she has deep experience in private equity, investment banking, and structured finance.

• Dr. Arun Atrey: Managing Director and CEO of Zenex, Dr. Atrey has four decades of experience in the animal health industry. He previously served as Managing Director of Zydus Animal Health and has been instrumental in introducing numerous groundbreaking veterinary products to the Indian market.

Zenex has made significant strides in obtaining regulatory approvals for its products in various international markets:

• United States: Zenex has pursued FDA facility registrations and is in the process of filing Abbreviated New Drug Applications (ANDAs) for its product portfolio. The company is also preparing Drug Master File (DMF) submissions to support its regulatory filings.

• European Union: Zenex is working towards obtaining European Medicines Agency (EMA) approvals for its key products, aligning with EU Good Manufacturing Practice (GMP) standards to facilitate market entry.

• United Kingdom: The company is in the process of registering its products with the Medicines and Healthcare products Regulatory Agency (MHRA), aiming to meet UK-specific regulatory requirements.

• Australia: Zenex is preparing to submit its product dossiers to the Therapeutic Goods Administration (TGA), ensuring compliance with Australian regulatory standards.

• Japan: The company is exploring the regulatory pathways for market access in Japan, focusing on obtaining necessary approvals from the Pharmaceuticals and Medical Devices Agency (PMDA).

Zenex is actively expanding its presence in emerging markets:

• Africa: The company has initiated export consignments of herbal dewormers and feed supplements to countries such as Kenya and Nigeria, aiming to address the growing demand for animal health products in the region.

• Latin America: Zenex is exploring partnerships and regulatory pathways to introduce its product range in countries like Brazil and Argentina, focusing on the livestock and poultry segments.

• Southeast Asia: The company has made initial shipments to markets including Thailand and Vietnam, with plans to expand its footprint through local collaborations and compliance with regional regulatory standards.

Zenex's commitment to quality is evident in its pursuit of WHO prequalification for select products, facilitating access to international markets and enhancing its global competitiveness.

Zenex's geographic strategy reflects a balanced approach to market diversification:

• Diversification Assessment: The company's export portfolio is diversified across multiple regions, including the Middle East, Africa, and Southeast Asia, reducing reliance on any single market.

• Concentration Risk: With a significant portion of its exports directed towards emerging markets, Zenex mitigates concentration risk by targeting a broad spectrum of geographies.

• Strategic Direction: Zenex is strategically positioning itself to leverage growth opportunities in both developed and emerging markets, aligning its product offerings with regional demands and regulatory landscapes.

Zenex is actively engaging with the U.S. Food and Drug Administration (FDA) to establish a presence in the U.S. market:

• FDA Facility Registrations: The company has initiated the registration of its manufacturing facilities with the FDA, ensuring compliance with U.S. regulatory standards.

• Approved ANDAs: Zenex is in the process of filing ANDAs for its key products, aiming to secure approval for marketing in the U.S.

• DMF Filings: The company is preparing DMF submissions to support its ANDA filings, providing detailed information on the manufacturing process and quality control measures.

• Inspection History: Zenex's manufacturing facilities are subject to FDA inspections to verify compliance with Current Good Manufacturing Practice (CGMP) regulations.

Zenex's commitment to quality is demonstrated through its adherence to international standards:

• WHO Prequalification: The company is pursuing WHO prequalification for select products, aiming to meet global standards and facilitate access to international markets.

• EU GMP Certificates: Zenex is working towards obtaining EU GMP certificates for its manufacturing facilities, ensuring compliance with European regulatory requirements.

• EDQM Status: The company is in the process of aligning its quality management systems with the European Directorate for the Quality of Medicines & HealthCare (EDQM) standards.

Zenex operates in compliance with Indian regulatory standards:

• CDSCO Manufacturing Licenses: The company holds manufacturing licenses issued by the Central Drugs Standard Control Organisation (CDSCO), authorizing the production of veterinary pharmaceutical products.

• State Drug Controller Approvals: Zenex has obtained approvals from state drug controllers for its manufacturing facilities, ensuring adherence to regional regulatory requirements.

• Export NOCs: The company has secured No Objection Certificates (NOCs) for export from the Directorate General of Foreign Trade (DGFT), facilitating international trade.

As of March 2026, Zenex has maintained a clean regulatory record:

• Form 483 Observations: There are no records of Form 483 observations issued by the FDA for Zenex's manufacturing facilities.

• Warning Letters: The company has not received any warning letters from regulatory authorities, indicating compliance with applicable regulations.

• Import Alerts: Zenex's products are not subject to any import alerts, reflecting the acceptability of its products in international markets.

Zenex operates in a competitive environment, with several key players in the animal health sector:

• Top Competitors: Major competitors include Zoetis India, Elanco Animal Health, and Boehringer Ingelheim India, all of which offer a range of veterinary pharmaceutical products.

• Market Share Comparison: While specific market share data is not publicly available, Zenex's focus on both allopathic and herbal formulations positions it uniquely in the market.

• Head-to-Head Analysis: Zenex differentiates itself through its dual approach of integrating modern veterinary medicine with Ayurvedic practices, catering to a diverse customer base seeking natural and conventional solutions.

Zenex's unique strengths include:

• Product Portfolio Distinctions: The company's integration of allopathic and herbal formulations allows it to address a wide spectrum of animal health needs,