Regulatory
Approvals & Certifications
Our facilities have been successfully inspected by the U.S. Food & Drug Administration (USFDA) and classified as Voluntary Action Indicated (VAI). This rating reflects our adherence to stringent cGMP (current Good Manufacturing Practice) norms with only minor observations, enabling us to export to the regulated U.S. market.
We are certified by the EDQM, allowing us to supply high-quality APIs to the European Union. This approval confirms our compliance with EU GMP standards and quality assurance systems.
Sai Sri Heterocyclics holds KFDA approval, permitting exports to South Korea. Our facilities meet all regulatory and GMP requirements established by the Korean authorities.
All our units follow WHO-GMP guidelines for pharmaceutical production. We implement robust quality systems and SOPs at every step, from raw material procurement to finished goods dispatch.
Commitment to Global Standards
With these approvals in place, Emnar Pharma is trusted by leading pharmaceutical companies worldwide. We consistently deliver reliable, safe, and effective pharmaceutical ingredients that meet or exceed global expectations.
Our accreditations ensure
- Global market access (U.S., EU, Korea, and more)
- Strong QMS and data integrity
- Full traceability and compliance audits
- Regulatory confidence in every shipment
Unit IV serves as EMNAR’s dedicated packaging and warehousing hub, with significant capacity—handling up to 500,000 fiber drums annually, available in various sizes to meet the diverse storage and transport needs of APIs and intermediates.
