Is Embio Limited FDA approved?

Embio 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 Embio Limited's drugs manufactured?

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

What drugs does Embio Limited make?

5 products are listed under Embio 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.

Embio Limited

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

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Registered sites: 1
Active NDC listings: 5
Live patents: 0
Countries: 1
Base: India

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Embio Limited	E-21, MIDC Industrial Estate,, Mahad, Maharashtra, Raigad 402309, India (IND)	Analytical testing, Active ingredient (API) manufacture	1000283831916512449

Catalogue

Drug listings by form and route

5 active NDC listings: 5 bulk ingredient. By marketing category: BULK INGREDIENT 5.

Dosage form	NDCs
powder	5

Route	NDCs

Labeller name on the listing	NDCs
embio limited	5

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Ephedrine Hydrochloride	powder	60646-101BULK INGREDIENT
-	Ephedrine Sulfate	powder	60646-104BULK INGREDIENT
-	Pseudoephedrine Hydrochloride	powder	60646-102BULK INGREDIENT
-	Pseudoephedrine Sulfate	powder	60646-103BULK INGREDIENT
-	Selegiline Hydrochloride	powder	60646-106BULK INGREDIENT

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Enquiry

Common questions

Is Embio Limited FDA approved?: Embio 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 Embio Limited's drugs manufactured?: The FDA register lists Maharashtra. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Embio Limited make?: 5 products are listed under Embio 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.