Nucleoside Metabolic Inhibitor
Where is Azacitidine made?
20 companies sell it under their own name. Their labels name 13 factories in India, Romania, Germany and China.
India 10Romania 1Germany 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Inc.100 mg · NDC 43598-678, 43598-465, 43598-305 +1 | DR Reddy's Laboratories LimitedMakes it and tests it | Srikakulam, India | Problems found, fixed voluntarilyJul 2025 |
| Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 | |
| Shilpa Medicare LimitedMakes it and tests it | Mahabubnagar, India | Serious problems, FDA actionFeb 2020 | |
| Accord Healthcare Inc.100 mg · NDC 16729-306 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| BluePoint Laboratories.100 mg · NDC 68001-313, 68001-620 | DR Reddy's Laboratories LimitedMakes it and tests it | Srikakulam, India | Problems found, fixed voluntarilyJul 2025 |
| Sindan-Pharma SrlMakes it, tests it, packages it and labels it | Bucharest, Romania | No problems foundAug 2024 | |
| Northstar Rx LLC.100 mg · NDC 16714-927 | DR Reddy's Laboratories LimitedMakes it and tests it | Srikakulam, India | Problems found, fixed voluntarilyJul 2025 |
| Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 | |
| AuroMedics Pharma LLC100 mg per 4 mL · NDC 55150-393 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Camber Pharmaceuticals Inc.100 mg · NDC 31722-365 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyJun 2026 |
| Civica, Inc.100 mg · NDC 72572-020 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Fresenius Kabi, LLC100 mg per 30 mL · NDC 63323-771 | Shilpa Medicare LimitedMakes it, tests it and packages it | Mahabubnagar, India | Serious problems, FDA actionFeb 2020 |
| Hikma Pharmaceuticals USA Inc.100 mg · NDC 0143-9606 | Thymoorgan GMBH PharmazieMakes it, tests it, packages it and labels it | Goslar OT Vienenburg, Germany | Problems found, fixed voluntarilyMar 2025 |
| MSN Laboratories Private Limited100 mg · NDC 69539-112 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Meitheal Pharmaceuticals Inc.100 mg · NDC 71288-153, 71288-115 | Kindos Pharmaceuticals Co., Ltd.Makes it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 |
| Panacea Biotec Limited100 mg per 50 mL · NDC 43817-906 | Panacea Biotec Pharma LimitedMakes it | Solan, India | Serious problems, FDA actionOct 2023 |
| Reliance Life Sciences Private Limited100 mg · NDC 58458-002 | Reliance Life Sciences Private LimitedMakes it, makes the active ingredient, tests it, packages it and labels it | Navi Mumbai, India | Serious problems, FDA actionFeb 2026 |
| Sandoz Inc.100 mg · NDC 0781-3491 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Somerset Therapeutics, LLC100 mg · NDC 70069-857 | Reliance Life Sciences Private LimitedMakes it, makes the active ingredient, tests it, packages it and labels it | Navi Mumbai, India | Serious problems, FDA actionFeb 2026 |
| Amneal Pharmaceuticals LLC100 mg · NDC 70121-1237 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.100 mg · NDC 60505-6271 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Armas Pharmaceuticals Inc.100 mg · NDC 72485-201 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Celgene Corporation Vidaza, Onureg100 mg, 200 mg, 300 mg · NDC 59572-102, 59572-730, 59572-740 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pilnova Pharma Inc100 mg · NDC 83774-102 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Jul 22, 2022 · Class III · Teva Pharmaceuticals USA Inc
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification. - Jan 19, 2022 · Class III · Dr. Reddy's Laboratories, Inc. · 2 recall notices
Failed stability specifications - Dec 8, 2020 · Class II · Shilpa Medicare Limited
CGMP Deviations
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.