Drug
Who makes azacitidine?
20 companies list azacitidine as a human prescription drug, including under the names ONUREG, VIDAZA. Forms: injection, powder, lyophilized, for solution; tablet, film coated. Routes: intravenous, oral, subcutaneous.
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 azacitidine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Dr. Reddy's Laboratories LimitedIndia | injection, powder, lyophilized, for solution | ANDAANDA201537, ANDA207518 | 4 | 15 |
| BluePoint Laboratories Inc. | injection, powder, lyophilized, for solution | ANDA, NDAANDA201537, ANDA207475, NDA208216 | 3 | 0 |
| Celgene International Sarl | injection, powder, lyophilized, for solution; tablet, film coated | NDANDA050794, NDA214120 | 3 | 0 |
| Excella GmbH & Co. KGGermany | tablet, film coated | DRUG FOR FURTHER PROCESSING | 2 | 1 |
| Meitheal Pharmaceuticals, Inc. | injection, powder, lyophilized, for solution | ANDAANDA212128 | 2 | 0 |
| MSN Laboratories Private Limited,India | injection, powder, lyophilized, for solution | ANDAANDA212580 | 1 | 8 |
| Apotex Inc.Canada | injection, powder, lyophilized, for solution | ANDAANDA215905 | 1 | 6 |
| Fresenius Kabi USA, LLCUnited States | injection, powder, lyophilized, for solution | ANDAANDA207518 | 1 | 6 |
| Sandoz Industrial Products S.AAustria | injection, powder, lyophilized, for solution | ANDAANDA212580 | 1 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | injection, powder, lyophilized, for solution | ANDAANDA209337 | 1 | 4 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | injection, powder, lyophilized, for solution | ANDAANDA207475 | 1 | 2 |
| Amneal Ireland LimitedIreland | injection, powder, lyophilized, for solution | ANDAANDA211549 | 1 | 1 |
| Camber Pharmaceuticals, Inc.United States | injection, powder, lyophilized, for solution | ANDAANDA215765 | 1 | 1 |
| Civica, Inc. dba CivicaRxUnited States | injection, powder, lyophilized, for solution | ANDAANDA212580 | 1 | 1 |
| PANACEA BIOTEC PHARMA LIMITEDIndia | injection, powder, lyophilized, for solution | ANDAANDA207234 | 1 | 1 |
| Reliance Life Sciences Private LimitedIndia | injection, powder, lyophilized, for solution | ANDAANDA217453 | 1 | 1 |
| Somerset Therapeutics Private LimitedIndia | injection, powder, lyophilized, for solution | ANDAANDA217453 | 1 | 1 |
| Armas Pharmaceuticals, Inc. | injection, powder, lyophilized, for solution | ANDAANDA207518 | 1 | 0 |
| Eugia US LLC | injection, powder, lyophilized, for solution | ANDAANDA215066 | 1 | 0 |
| NorthStar RxLLC | injection, powder, lyophilized, for solution | ANDAANDA201537 | 1 | 0 |
Bulk ingredient listings
- LAURUS LABS LIMITEDIndia · 2 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Chongqing Sintaho Pharmaceutical Co., Ltd.China · 1 NDC
- Hetero Labs LimitedIndia · 1 NDC
- Huzhou Zhanwang Pharmaceutical Co., Ltd.China · 1 NDC
- Jiangsu Hansoh Pharmaceutical Group Co., Ltd.China · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Olon USA LLCItaly · 1 NDC
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Sicor S.r.l. · 1 NDC
- Sicor de Mexico S.A. de C.V.Mexico · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Valary Lab Private LimitedIndia · 1 NDC
- Wuhan Biocause Pharmaceutical Development Co., Ltd · 1 NDC
Orange Book patents
3 unexpired patents list azacitidine as the active ingredient, expiring between May 2029 and Jun 2030. Application holder: BRISTOL MYERS SQUIBB CO.
Enquiry
Common questions
- Who makes azacitidine?
- 20 companies list azacitidine as a human prescription drug in the openFDA NDC Directory, led by Dr. Reddy's Laboratories Limited, BluePoint Laboratories Inc., Celgene International Sarl, Excella GmbH & Co. KG, 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 ONUREG?
- 18 companies list azacitidine 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 azacitidine active ingredient?
- 15 companies list azacitidine as a bulk ingredient, including LAURUS LABS LIMITED, Aurobindo Pharma Limited, Chongqing Sintaho Pharmaceutical Co., Ltd., Hetero Labs Limited.