Is Bioxera Pharma Private Limited FDA approved?

Bioxera Pharma 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 Bioxera Pharma Private Limited's drugs manufactured?

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

What drugs does Bioxera Pharma Private Limited make?

4 products are listed under Bioxera Pharma 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.

Bioxera Pharma Private Limited

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

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Registered sites: 1
Active NDC listings: 4
Live patents: 0
Countries: 1
Base: India

Authorisation

Registered operations

Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Bioxera Pharma Private Limited	Plot No. N-57, Additional Ambernath MIDC, Anand Nagar, Ambernath East, Dist. Thane, Ambernath, Maharashtra 421506, India (IND)	Active ingredient (API) manufacture	3010166801650630457

Catalogue

Drug listings by form and route

4 active NDC listings: 4 bulk ingredient. By marketing category: BULK INGREDIENT 4.

Dosage form	NDCs
powder	4

Route	NDCs

Labeller name on the listing	NDCs
bioxera pharma private limited	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Clomiphene Citrate	powder	53211-212BULK INGREDIENT
-	Cyclopentolate Hydrochloride	powder	53211-214BULK INGREDIENT
-	Enclomiphene Citrate	powder	53211-211BULK INGREDIENT
-	Tropicamide	powder	53211-213BULK INGREDIENT

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Enquiry

Common questions

Is Bioxera Pharma Private Limited FDA approved?: Bioxera Pharma 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 Bioxera Pharma Private Limited's drugs manufactured?: The FDA register lists Ambernath. Registered operations: active ingredient (API) manufacture.
What drugs does Bioxera Pharma Private Limited make?: 4 products are listed under Bioxera Pharma 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.