9 companies list thiotepa as a human prescription drug in the openFDA NDC Directory, led by Amneal Ireland Limited, Hikma Pharmaceuticals USA Inc., Dr. Reddy's Laboratories Limited, GLAND PHARMA LIMITED, Meitheal Pharmaceuticals, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.

Is there a generic TEPADINA?

7 companies list thiotepa under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.

Who supplies thiotepa active ingredient?

5 companies list thiotepa as a bulk ingredient, including Heraeus Precious Metals GmbH Co KG, Indena SpA, MSN Laboratories Private Limited,, NATCO PHARMA LIMITED.

Drug

Who makes thiotepa?

9 companies list thiotepa as a human prescription drug, including under the names TEPADINA, TEPYLUTE. Forms: injection; injection, powder, for solution; injection, powder, lyophilized, for solution. Routes: intracavitary, intravenous, intravesical.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing thiotepa

Company	Forms	Application	NDCs	Registered sites
Amneal Ireland LimitedIreland	injection, powder, for solution; injection, powder, lyophilized, for solution	NDANDA208264	4	1
Hikma Pharmaceuticals USA Inc.United States	injection, powder, lyophilized, for solution	ANDAANDA075547, ANDA211755	3	4
Dr. Reddy's Laboratories LimitedIndia	injection, powder, lyophilized, for solution	ANDAANDA210337, ANDA214222	2	15
GLAND PHARMA LIMITEDIndia	injection, powder, lyophilized, for solution	ANDAANDA214222	2	4
Meitheal Pharmaceuticals, Inc.	injection, powder, for solution	ANDAANDA216037	2	0
Novadoz Pharmaceuticals LLC	injection, powder, lyophilized, for solution	ANDAANDA213049	2	0
Shorla Oncology Inc.,	injection	NDANDA216984	2	0
Fresenius Kabi USA, LLCUnited States	injection, powder, lyophilized, for solution	ANDAANDA214222	1	6
Sagent Pharmaceuticals	injection, powder, lyophilized, for solution	ANDAANDA209150	1	0

Bulk ingredient listings

Heraeus Precious Metals GmbH Co KGGermany · 1 NDC
Indena SpAItaly · 1 NDC
MSN Laboratories Private Limited,India · 1 NDC
NATCO PHARMA LIMITEDIndia · 1 NDC
Pacific Medical Industries LtdUnited States · 1 NDC

Orange Book patents

3 unexpired patents list thiotepa as the active ingredient, expiring between May 2037 and Aug 2041. Application holders: ADIENNE SA, SHORLA PHARMA LTD.

Enquiry

Common questions

Who makes thiotepa?: 9 companies list thiotepa as a human prescription drug in the openFDA NDC Directory, led by Amneal Ireland Limited, Hikma Pharmaceuticals USA Inc., Dr. Reddy's Laboratories Limited, GLAND PHARMA LIMITED, Meitheal Pharmaceuticals, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic TEPADINA?: 7 companies list thiotepa under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies thiotepa active ingredient?: 5 companies list thiotepa as a bulk ingredient, including Heraeus Precious Metals GmbH Co KG, Indena SpA, MSN Laboratories Private Limited,, NATCO PHARMA LIMITED.