Alkylating Drug
Where is Temozolomide made?
13 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 8 factories in India, the United States, Italy and Turkey.
India 5United States 1Italy 1Turkey 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg · NDC 16729-050, 16729-129, 16729-130 +3 | 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 | |
| Lannett Company, Inc.5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg · NDC 0527-1779, 0527-1780, 0527-1781 +3 | Lannett Company, Inc.Makes it | Location not on file | Not inspected on record |
| Lannett Company, Inc.Makes it, tests it, packages it and labels it | Location not on file | Not inspected on record | |
| Amneal Pharmaceuticals5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg · NDC 65162-803, 65162-804, 65162-805 +3 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Areva Pharmaceuticals, Inc.5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg · NDC 59923-707, 59923-708, 59923-710 +8 | NerPharMa S.r.lMakes it | Nerviano, Italy | Problems found, fixed voluntarilySep 2024 |
| Ascend Laboratories, LLC5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg · NDC 67877-539, 67877-540, 67877-541 +3 | Deva Holding Anonim Sirketi - Cerkezkoy 2 Uretim Tesisi SubesiMakes it | Tekirdag, Turkey | No problems foundDec 2023 |
| Camber Pharmaceuticals Inc.5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg · NDC 31722-413, 31722-414, 31722-415 +3 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Caraco Pharmaceutical Laboratories, Ltd.5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg · NDC 47335-892, 47335-929, 47335-930 +3 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| CivicaScript LLC5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg · NDC 82249-408, 82249-410, 82249-412 +3 | Deva Holding Anonim Sirketi - Cerkezkoy 2 Uretim Tesisi SubesiMakes it | Tekirdag, Turkey | No problems foundDec 2023 |
| Devatis, Inc.5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg · NDC 73043-013, 73043-014, 73043-015 +3 | Deva Holding Anonim Sirketi - Cerkezkoy 2 Uretim Tesisi SubesiMakes it | Tekirdag, Turkey | No problems foundDec 2023 |
| Rising Pharma Holdings, Inc.5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg · NDC 16571-818, 16571-819, 16571-820 +3 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Merck Sharp & Dohme LLC Temodar2.5 mg per 1 mL, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg · NDC 0085-1366, 0085-1425, 0085-1430 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Nivagen Pharmaceuticals, Inc.5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg · NDC 75834-143, 75834-144, 75834-145 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| OPKO Pharmaceuticals LLC5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg · NDC 70301-2005, 70301-2007, 70301-2009 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Temozolomide 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:
72162-2661,72162-2662,72162-2663,72162-2660+2 - Physicians Total Care, Inc.:
54868-5350,54868-5980,54868-4142,54868-5354+1
Recalls
- Mar 3, 2026 · Class II · Rising Pharma Holding, Inc.
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing - Jul 16, 2019 · Class II · Deva Holding AS - Cerkezkoy Subesi · 6 recall notices
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. - Dec 12, 2012 · Class II · Schering-Plough Products, LLC
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.