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Quality

The Licences Behind the Label

Anyone can print "certified" on a pack. Here are the actual licences and certificate numbers for the facility that makes Hepatolean, with their validity dates — so you can check rather than take our word for it.

FSSAI Central Licence GMP & HACCP ISO 9001:2015
Who makes it

Formulated Here, Manufactured Under Licence

Hepatolean is formulated by Dr. Ankit Anand, a practising gastroenterologist, and manufactured to that specification by a licensed contract manufacturer in India.

All the certifications listed on this page are held by that manufacturing facility. We publish the numbers so you can verify them independently.

Manufacturing partner
Bioxent Health and Nutrition Pvt. Ltd.

An FSSAI-licensed, GMP-certified nutraceutical manufacturing unit in India. The licence and certificate numbers below belong to this facility.

On record

Licences & Certificates

Every number below is the real one. Validity dates are shown as issued — if a date has passed, please tell us and we will update it.

FSSAI central licence certificate for the Hepatolean manufacturing facility View full size

FSSAI Licensed

Central licence from the Food Safety and Standards Authority of India, the regulator for all food and nutraceutical manufacture in the country.

Licence No.
12723999000427
Category
Manufacturer — Food & Health Supplements and Nutraceuticals
Valid until 19 May 2028
GMP certificate for the Hepatolean manufacturing facility View full size

GMP Certified

Good Manufacturing Practice certification for nutraceutical manufacturing — covering hygiene, process control and record-keeping on the production floor.

Certificate No.
GMP/230620/XXXX
Valid until 21 April 2029
ISO 9001:2015 quality management certificate for the Hepatolean manufacturing facility View full size

ISO 9001:2015

Quality Management Systems certification — the international standard for how a facility documents, audits and improves its processes.

Certificate No.
QMS/230620/4269
Valid until 27 January 2028
HACCP food safety certificate for the Hepatolean manufacturing facility View full size

HACCP Certified

Hazard Analysis and Critical Control Point certification — a food-safety system that identifies risk points in production and controls them at source.

Certificate No.
HACCP/230620/1273
Valid until 16 July 2027
US FDA compliance assessment report for the Hepatolean manufacturing facility View full size

US FDA Compliance Assessment

A third-party review of the facility against applicable FDA guidelines for dietary-supplement manufacture.

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.

Vegetarian & Honest Label

Hepatolean carries the green vegetarian mark. Every active is printed on the pack at its actual dose — no proprietary blends, no added sugar.

Added sugar
Zero
Sweetened with
Stevia & monk fruit
Contains
Milk, soy lecithin
Straight talk

What These Certificates Do — and Don't — Mean

Certifications get used loosely in this category. Here is exactly what ours cover, so nothing is oversold.

What they do mean
  • The facility is licensed by FSSAI to manufacture food and health supplements in India
  • Production follows documented GMP hygiene and process controls
  • Food-safety risk points are identified and controlled under HACCP
  • The quality management system is audited against ISO 9001:2015
  • Licence and certificate numbers are published here, not just claimed
What they do not mean
  • They are not a drug approval. No food supplement in India carries one
  • FSSAI licensing is not the same as US FDA approval, and we never describe it that way
  • They do not certify that the product treats, cures or prevents any disease
  • They are held by the manufacturing facility, not by an individual product batch
Questions

Quality, Answered Plainly

Is an FSSAI licence the same as FDA approval?

No. FSSAI is India's food safety regulator. It licences the manufacture and sale of food products, including nutritional supplements. It is not a drug approval, and no supplement sold in India carries one.

Anyone describing a protein powder as "FDA approved" is misrepresenting what that phrase means.

Then what is the US FDA certificate on this page?

It is a third-party compliance assessment — an independent body reviewed the facility against applicable FDA guidelines and issued a report.

It is not an approval, endorsement or registration by the U.S. Food and Drug Administration, and we do not present it as one.

Are these certificates yours or the factory's?

They are held by the manufacturing facility, Bioxent Health and Nutrition Pvt. Ltd., which produces Hepatolean to Dr. Anand's formulation specification.

That is how contract manufacturing works across the supplement industry. We publish the facility's numbers rather than implying the certificates are ours.

Who formulated the product?

Dr. Ankit Anand, a DrNB-qualified gastroenterologist and hepatologist practising in Jalandhar, Punjab. Read his full story.

Is Hepatolean vegetarian?

Yes — it carries the green vegetarian mark. It is whey-based, so it contains milk, and it also contains soy lecithin. It is not suitable for vegans, or for anyone with a milk or soy allergy.

Can I see the actual documents?

Yes. Email support@hepatolean.com with the certificate you would like to see and we will send you a copy.

Get in touch

Dr. Anand's Wellness (Hepatolean)

Want to verify a licence, or ask for a copy of a certificate? Write to us and we will send it across.

Address
558 Guru Teg Bahadur Nagar,
Near Prithvi Planet,
Jalandhar, Punjab 144003, India
Phone

Hepatolean products are nutritional supplements and are not intended to diagnose, treat, cure or prevent any disease or condition. Always consult your physician regarding your individual health needs. Certificate details on this page relate to the manufacturing facility and are reproduced as issued.