Drug
Who makes temozolomide?
12 companies list temozolomide as a human prescription drug, including under the names TEMODAR. Forms: capsule; injection, powder, lyophilized, for solution. Routes: intravenous, oral.
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 temozolomide
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Merck Sharp & Dohme Corp. | capsule; injection, powder, lyophilized, for solution | NDANDA021029, NDA022277 | 7 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | capsule | ANDAANDA201742 | 6 | 13 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | capsule | ANDAANDA201528 | 6 | 2 |
| Nivagen Pharmaceuticals LLCUnited States | capsule | ANDAANDA213328 | 6 | 2 |
| Amneal Ireland LimitedIreland | capsule | ANDAANDA203691 | 6 | 1 |
| Bryant Ranch PrepackUnited States | capsule | ANDAANDA207658 | 6 | 1 |
| Camber Pharmaceuticals, Inc.United States | capsule | ANDAANDA210030 | 6 | 1 |
| Rising Pharma Holdings, Inc.United States | capsule | ANDAANDA206309 | 6 | 1 |
| ASCEND Therapeutics US, LLC | capsule | ANDAANDA207658 | 6 | 0 |
| CivicaScript, LLC | capsule | ANDAANDA207658 | 6 | 0 |
| Devatis, Inc. | capsule | ANDAANDA207658 | 6 | 0 |
| OPKO Pharmaceuticals, LLC | capsule | ANDAANDA203898 | 4 | 0 |
Bulk ingredient listings
- Excella GmbH & Co. KGGermany · 3 NDC
- Pacific Medical Industries LtdUnited States · 2 NDC
- Formosa Laboratories, Inc.Taiwan · 1 NDC
- Hetero Labs LimitedIndia · 1 NDC
- Hubei Haosun Pharmaceutical Co., Ltd.China · 1 NDC
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Valary Lab Private LimitedIndia · 1 NDC
- WAVELENGTH ENTERPRISES LTDIsrael · 1 NDC
Enquiry
Common questions
- Who makes temozolomide?
- 12 companies list temozolomide as a human prescription drug in the openFDA NDC Directory, led by Merck Sharp & Dohme Corp., Sun Pharmaceutical Industries Limited, ACCORD HEALTHCARE LIMITED, Nivagen Pharmaceuticals LLC, Amneal Ireland Limited. 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 TEMODAR?
- 11 companies list temozolomide under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies temozolomide active ingredient?
- 9 companies list temozolomide as a bulk ingredient, including Excella GmbH & Co. KG, Pacific Medical Industries Ltd, Formosa Laboratories, Inc., Hetero Labs Limited.