Is Praveen Laboratories Private Limited FDA approved?

Praveen Laboratories Private Limited 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 Praveen Laboratories Private Limited's drugs manufactured?

The FDA register lists Surat. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does Praveen Laboratories Private Limited make?

2 products are listed under Praveen Laboratories Private Limited in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Praveen Laboratories Private Limited

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

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Registered sites: 1
Active NDC listings: 2
Live patents: 0
Countries: 1
Base: India

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
PRAVEEN LABORATORIES PRIVATE LIMITEDRegistrant: Praveen Laboratories Private Limited	Block No 206, Moje Jolwa, Tal Palsana, Surat, Gujarat 394305, India (IND)	Analytical testing, Active ingredient (API) manufacture	3005751252863318468

Catalogue

Drug listings by form and route

2 active NDC listings: 2 bulk ingredient. By marketing category: BULK INGREDIENT 1, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 1.

Dosage form	NDCs
powder	2

Route	NDCs

Labeller name on the listing	NDCs
praveen laboratories private limited	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Cetirizine Hydrochloride	powder	87307-001BULK INGREDIENT
-	Clopidogrel Bisulfate	powder	87307-002BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

Neighbours

Registered in the same town

ACUTAAS CHEMICALS LIMITEDSurat, IND
CTX Lifesciences Pvt. Ltd.Surat, IND
Eskay Speciality ChemicalsSurat, IND
Globela Pharma Pvt. Ltd.Surat, IND
MEDILANE HEALTHCARE PRIVATE LIMITEDSurat, IND

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Enquiry

Common questions

Is Praveen Laboratories Private Limited FDA approved?: Praveen Laboratories Private Limited 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 Praveen Laboratories Private Limited's drugs manufactured?: The FDA register lists Surat. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Praveen Laboratories Private Limited make?: 2 products are listed under Praveen Laboratories Private Limited in the openFDA NDC Directory, most often as powder. 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.