Nucleoside Metabolic Inhibitor
Where is Decitabine made?
19 companies sell it under their own name and 1 repackager rebottle it. Their labels name 11 factories in India, Malta, China and Switzerland.
India 8Malta 1China 1Switzerland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| BluePoint Laboratories.50 mg per 10 mL, 50 mg per 20 mL · NDC 68001-642, 68001-713, 68001-618 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyJun 2026 |
| MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 | |
| Qilu Pharmaceutical (Hainan) Co., Ltd.Makes it, tests it and packages it | Haikou, China | Problems found, fixed voluntarilyMay 2023 | |
| Accord Healthcare Inc.50 mg per 20 mL · NDC 16729-224 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 |
| Amneal Pharmaceuticals LLC50 mg per 20 mL · NDC 70121-1644 | Kelix bio (Malta) Ltd.Makes it | Birzebbugia, Malta | Problems found, fixed voluntarilyDec 2022 |
| AuroMedics Pharma LLC50 mg per 26 mL · NDC 55150-376 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Camber Pharmaceuticals Inc.50 mg per 10 mL · NDC 31722-304 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyJun 2026 |
| Caraco Pharmaceutical Laboratories, Ltd.50 mg per 10 mL · NDC 47335-361 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Dr. Reddy's Laboratories Inc.50 mg per 10 mL · NDC 43598-427 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Dr.Reddy's Laboratories Ltd.50 mg per 10 mL · NDC 55111-556 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Gland Pharma Limited50 mg per 10 mL · NDC 68083-528 | Gland Pharma LimitedMakes it, tests it and packages it | Visakhapatnam, India | No problems foundJul 2023 |
| Ingenus Pharmaceuticals, LLC50 mg · NDC 50742-430 | Avyxa GmbHMakes it, tests it, packages it, labels it and sterilizes it | Barbengo, Switzerland | Problems found, fixed voluntarilyOct 2024 |
| Lupin Pharmaceuticals, Inc.50 mg per 20 mL · NDC 68180-738 | Shilpa Medicare LimitedMakes it | Mahabubnagar, India | Serious problems, FDA actionFeb 2020 |
| Northstar Rx LLC.50 mg per 10 mL · NDC 72603-107 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Novadoz Pharmaceuticals LLC50 mg per 10 mL · NDC 72205-036, 72205-031 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Qilu Pharmaceutical Co., Ltd.50 mg per 20 mL · NDC 67184-0535 | Qilu Pharmaceutical (Hainan) Co., Ltd.Makes it and tests it | Haikou, China | Problems found, fixed voluntarilyMay 2023 |
| Hikma Pharmaceuticals USA Inc.50 mg · NDC 0143-9385 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Meitheal Pharmaceuticals Inc.50 mg per 20 mL · NDC 71288-119 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC50 mg per 20 mL · NDC 67457-316 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Nivagen Pharmaceuticals, Inc.50 mg per 20 mL · NDC 75834-190 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals50 mg per 20 mL · NDC 25021-219 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Decitabine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Bryant Ranch Prepack:
72162-2634
Recalls
- Jul 2, 2024 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.