The certifications below are held by our manufacturing partner, Bioxent Health and Nutrition Pvt. Ltd., the facility where Hepatolean products are made. The page states this clearly — it’s accurate and it’s what builds real trust.
Certified Quality You Can Trust
At Hepatolean, quality isn’t a claim — it’s certified. Every Hepatolean product is manufactured in India by Bioxent Health and Nutrition Pvt. Ltd., a facility that meets some of the most respected food-safety and quality-management standards in the industry. Here’s exactly what that means for you.
FSSAI Licensed
Our products are manufactured under a Central FSSAI licence from the Food Safety and Standards Authority of India — the government body that regulates food and health supplements in India.
- What it means for you: the product is legally manufactured and meets India’s food-safety requirements.
- Licence No.: 12723999000427
- Category: Manufacturer – Food & Health Supplements and Nutraceuticals
- Valid up to: 19 May 2028
GMP Certified (Good Manufacturing Practice)
The facility is certified for Good Manufacturing Practice for nutraceutical manufacturing — the global benchmark for how a supplement should be made.
- What it means for you: every batch is produced under controlled, consistent, hygienic processes.
- Scope: Nutraceutical products manufacturing
- Certificate No.: GMP/230620/XXXX
- Valid up to: 21 April 2029
ISO 9001:2015 Certified
The facility holds ISO 9001:2015, the internationally recognised standard for Quality Management Systems.
- What it means for you: quality is managed and monitored across the entire production process, not left to chance.
- Certificate No.: QMS/230620/4269
- Valid up to: 27 January 2028
HACCP Certified
The facility is HACCP certified (Hazard Analysis and Critical Control Point) — the global food-safety system that identifies and controls risks at every stage of production.
- What it means for you: food-safety hazards are actively prevented, not just checked at the end.
- Scope: Manufacturer of premium certified nutraceuticals, including vitamins, minerals, protein powders and herbal extracts
- Certificate No.: HACCP/230620/1273
- Valid up to: 16 July 2027
Assessed for US FDA Regulatory Compliance
The facility has been independently assessed for compliance with US FDA regulatory guidelines for food and nutraceuticals by a third-party certification body.
- What it means for you: the manufacturing practices have been reviewed against internationally referenced US FDA guidelines.
- Certificate No.: US-BXTN-24-2411284
- This is a third-party compliance assessment. It is not an approval, endorsement or registration by the U.S. Food and Drug Administration.
Our Commitment
Alongside these facility certifications, every Hepatolean formula is created by Dr. Ankit Anand, a gastroenterologist, with honest labelling, no added sugar and no exaggerated claims. Quality you can verify — from the formula to the factory.
Hepatolean products are nutritional supplements and are not intended to diagnose, treat, cure or prevent any disease or condition.