Is Aurolab FDA approved?

Aurolab holds 1 FDA-registered establishment in India. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Aurolab's drugs manufactured?

The FDA register lists Madurai. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Aurolab make?

8 products are listed under Aurolab in the openFDA NDC Directory, most often as for solution; solution; solution, gel forming / drops. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Aurolab

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 8
Live patents: 0
Countries: 1
Base: India

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
AUROLAB TRUST DBA AurolabRegistrant: Aurolab	1, Sivagangai Main Road, Veerapanjan, Madurai, Tamil Nadu 625020 India, India (IND)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002957101677319965

Catalogue

Drug listings by form and route

8 active NDC listings: 8 human otc drug. By marketing category: OTC MONOGRAPH DRUG 8.

Dosage form	NDCs
for solution	4
solution	3
solution, gel forming / drops	1

Route	NDCs
topical	5
ophthalmic	3

Labeller name on the listing	NDCs
aurolab	8

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
AURO-CMC	Carboxymethylcellulose Eye Drops 0.5%	for solution, topical	16030-401OTC MONOGRAPH DRUG
Aurodone Povidone Iodine 5 % Opthalmic Solution	Povidone Iodine 5 % Topical Solution	solution, topical	16030-601OTC MONOGRAPH DRUG
Aurovisc	Hypromellose Ophthalmic Solution 2% w/v	solution, ophthalmic	16030-301OTC MONOGRAPH DRUG
Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Gel/Drops	Hypromellose Ophthalmic Solution 2% w/v	solution, gel forming / drops, ophthalmic	16030-303OTC MONOGRAPH DRUG
Aurovisc OE	Hypromellose Ophthalmic Solution 2% w/v	solution, ophthalmic	16030-304OTC MONOGRAPH DRUG
Carboxymethylcellulose Sodium Eye Drops 0.5%	Carboxymethylcellulose Sodium Eye Drops 0.5%	for solution, topical	16030-501OTC MONOGRAPH DRUG
Hypromellose Eye Drops 0.7%	Hypromellose Eye Drops 0.7%	for solution, topical	16030-101OTC MONOGRAPH DRUG
Polyvinyl Alcohol Eye Drops 1,4 % w/v	Polyvinyl Alcohol Eye Drops 1,4 % w/v	for solution, topical	16030-201OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Kothari Phytochemicals InternationalMadurai, IND

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Enquiry

Common questions

Is Aurolab FDA approved?: Aurolab holds 1 FDA-registered establishment in India. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Aurolab's drugs manufactured?: The FDA register lists Madurai. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Aurolab make?: 8 products are listed under Aurolab in the openFDA NDC Directory, most often as for solution; solution; solution, gel forming / drops. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.