Is SPICA LABORATORIES PRIVATE LIMITED FDA approved?

SPICA 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 SPICA LABORATORIES PRIVATE LIMITED's drugs manufactured?

The FDA register lists Choutuppal. Registered operations: active ingredient (API) manufacture.

What drugs does SPICA LABORATORIES PRIVATE LIMITED make?

2 products are listed under SPICA 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.

SPICA 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
Labeller names: 2
Live patents: 0
Countries: 1
Base: India

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Spica Laboratories Private LimitedRegistrant: SPICA LABORATORIES PRIVATE LIMITED	Sy No 270/C2, S Lingotam Village, Choutuppal, Telangana 508252, India (IND)	Active ingredient (API) manufacture	3030125048869737612

Catalogue

Drug listings by form and route

2 active NDC listings: 2 bulk ingredient. By marketing category: BULK INGREDIENT 2.

Dosage form	NDCs
powder	2

Route	NDCs

Labeller name on the listing	NDCs
spica laboratories private limited	1
spica laboratories private limited	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Nicotinamide Adenine Dinucleotide	powder	84040-001BULK INGREDIENT
-	Topiramate	powder	84040-003BULK INGREDIENT

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Enquiry

Common questions

Is SPICA LABORATORIES PRIVATE LIMITED FDA approved?: SPICA 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 SPICA LABORATORIES PRIVATE LIMITED's drugs manufactured?: The FDA register lists Choutuppal. Registered operations: active ingredient (API) manufacture.
What drugs does SPICA LABORATORIES PRIVATE LIMITED make?: 2 products are listed under SPICA 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.