Is HORSTER BIOTEK PRIVATE LIMITED FDA approved?

HORSTER BIOTEK 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 HORSTER BIOTEK PRIVATE LIMITED's drugs manufactured?

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

What drugs does HORSTER BIOTEK PRIVATE LIMITED make?

6 products are listed under HORSTER BIOTEK 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.

HORSTER BIOTEK PRIVATE LIMITED

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

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Registered sites: 1
Active NDC listings: 6
Live patents: 0
Countries: 1
Base: India

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
HORSTER BIOTEK PRIVATE LIMITED	Khasra No.259, Plot No.1 & 2, Village Sukhliya, Sanwer Road Industrial Area, Indore, Madhya Pradesh 452015, India (IND)	Active ingredient (API) manufacture	3020665163873679552

Catalogue

Drug listings by form and route

6 active NDC listings: 6 bulk ingredient. By marketing category: BULK INGREDIENT 3, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 3.

Dosage form	NDCs
powder	6

Route	NDCs

Labeller name on the listing	NDCs
horster biotek pvt ltd.	6

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	METHYLCOBALAMIN	powder	85568-005BULK INGREDIENT
-	OXANDROLONE	powder	85568-001BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	OXYMETHOLONE	powder	85568-002BULK INGREDIENT
-	PROGESTERONE	powder	85568-004BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	STANOZOLOL	powder	85568-003BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	TADALAFIL	powder	85568-006BULK INGREDIENT

Neighbours

Registered in the same town

CIPLA PHARMACEUTICALS LIMITEDIndore, IND
Encube Ethicals LimitedIndore, IND
Symbiotec Pharmalab LimitedIndore, IND

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Enquiry

Common questions

Is HORSTER BIOTEK PRIVATE LIMITED FDA approved?: HORSTER BIOTEK 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 HORSTER BIOTEK PRIVATE LIMITED's drugs manufactured?: The FDA register lists Indore. Registered operations: active ingredient (API) manufacture.
What drugs does HORSTER BIOTEK PRIVATE LIMITED make?: 6 products are listed under HORSTER BIOTEK 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.