Certifications

This is a slogan about certification

Our manufacturing facility is licensed by the Central Drugs Standard Control Organization (CDSCO), the national regulatory authority under the Ministry of Health and Family Welfare, Government of India. This licensure certifies that our site is authorised to manufacture pharmaceutical products under the Drugs and Cosmetics Act, operating in compliance with Schedule M—India’s adaptation of Good Manufacturing Practices (GMP), harmonised with international standards, including those of the U.S. FDA and EMA.

As part of this certification:

  • We maintain controlled environments and classified cleanrooms, designed and validated to meet stringent air quality and hygiene requirements per ISO 14644-1 classifications.
  • Cross-contamination risks are actively mitigated through facility zoning, segregated production areas, validated sanitation protocols, and environmental controls.
  • Personnel follow strict gowning procedures and controlled access protocols, while materials are transferred via airlocks and pass boxes to maintain sterility and product safety.
  • Our operations follow standardised GMP protocols to ensure batch-to-batch consistency, product integrity, and full traceability.
  • In-process and batch release testing is governed by validated analytical methods.
  • Comprehensive quality risk management and quality assurance oversight underpin all manufacturing operations, from raw material intake to finished goods dispatch.
  • We implement robust contamination control strategies, including material and personnel movement procedures, validated cleaning and sanitisation, and real-time environmental monitoring.
  • Our facility design and operational flows are structured to eliminate cross-contamination risk, ensuring the safe handling of APIs, excipients, and finished formulations.

Our CDSCO drug license is more than regulatory compliance—it’s an affirmation of our commitment to manufacturing excellence at a level expected by global pharma leaders.

Antrix is GreenPro Certified by the Confederation of Indian Industry (CII). This certification is an affirmation of our commitment to environmental sustainability by ensuring that our products and practices meet the highest standards of environmental safety.

This certification affirms that:

  • Our products are rigorously tested and safe for disposal, especially for aquatic life.
  • Our materials and practices are proved to be environmentally safe throughout the entire lifecycle of our products – from development to production, and from packaging to disposal.
  • Our factory designs and SOPs ensure efficient waste management, rainwater harvesting, and water recycling.

ISO 9001 is a globally recognized benchmark for quality management. Our Quality Management System (QMS) is built on the principles of ISO 9001, and we have rigorously established, implemented, maintained, and continuously improved our processes in alignment with these standards. This ensures we operate with robust procedures and well-trained personnel, enabling us to deliver flawless products and services on a consistent basis.

Compliance with EN Norms for Antimicrobial Efficacy

The following disinfectant and antimicrobial formulations have been tested and verified in accordance with applicable European Norms (EN), demonstrating compliance with internationally recognised efficacy thresholds under standardized test conditions:

  • EN 13624 – Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area. The formulation meets the requirement of ≥5-log reduction (99.999%) against reference fungal and yeast strains (e.g., Candida albicans, Aspergillus brasiliensis), confirming efficacy for use in clinical and healthcare environments. 

  • EN 13697 – Quantitative non-porous surface test without mechanical action for the evaluation of bactericidal and/or fungicidal activity. Demonstrates ≥4-log reduction (99.99%) in bacterial and fungal loads on hard surfaces under simulated practical conditions. This test supports applications in food industry, institutional hygiene, and general environmental disinfection. 

  • EN 13727 – Quantitative suspension test for the evaluation of bactericidal activity in the medical area. Confirms ≥5-log reduction in vegetative bacterial cells (e.g., Staphylococcus aureus, Enterococcus hirae) in suspension, verifying suitability for high-risk clinical use where pathogen control is critical. 

  • EN 14348 – Quantitative suspension test for the evaluation of mycobactericidal activity in the medical area. Establishes ≥4-log reduction in Mycobacterium spp. (e.g., Mycobacterium terrae, Mycobacterium avium), validating the product’s use in medical environments requiring control of tuberculosis and non-tuberculous mycobacteria.

Our disinfectant and hygiene formulations are specifically developed to support and comply with the infection prevention and control protocols outlined by the National Accreditation Board for Hospitals & Healthcare Providers (NABH). As part of our commitment to healthcare safety, each product is engineered to meet the stringent disinfection, sterilisation, and environmental hygiene expectations mandated under NABH guidelines for accredited medical institutions.

Key Compliance Attributes:

  • Broad-Spectrum Efficacy: Our products are tested to relevant European Norms (EN) such as EN 13727, EN 13624, and EN 14476, ensuring validated action against bacteria, fungi, yeasts, mycobacteria, and viruses—including high-risk, hospital-associated pathogens.
  • Surface and Instrument Compatibility: Formulations are designed for compatibility with medical-grade surfaces and sensitive equipment, as required by NABH’s environmental hygiene and biomedical device protocols.
  • Cross-Contamination Control: In alignment with NABH standards on hospital-acquired infection (HAI) prevention, our formulations contribute to reducing microbial load in critical areas such as ICUs, OTs, wards, and isolation rooms.
  • Documentation & Validation: Each batch is manufactured under GMP-certified conditions and is accompanied by COAs, microbial efficacy reports, and technical documentation that supports traceability and regulatory audits under NABH norms.
  • Safe for Frequent Use: Products are non-corrosive, non-sensitising, and safe for routine use in high-contact areas, ensuring they support—not compromise—daily operational hygiene practices.

Our products are trusted by NABH-accredited hospitals and healthcare institutions nationwide. We partner closely with infection control teams to ensure seamless integration of our hygiene systems into SOPs, training protocols, and audit frameworks.