Nucleoside Metabolic Inhibitor
Where is Capecitabine made?
20 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 13 factories in India, Germany and Italy.
India 11Germany 1Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.150 mg, 500 mg · NDC 16729-072, 16729-073 | 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 | |
| Cipla USA., Inc.150 mg, 500 mg · NDC 69097-949, 69097-948 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| MSN Organics Private LimitedMakes the active ingredient | Yadadri Bhuvanagiri District, India | Problems found, fixed voluntarilyMar 2023 | |
| H2-Pharma LLC Xeloda150 mg, 500 mg · NDC 61269-470, 61269-475 | Excella GmbH & Co. KGMakes it, tests it, packages it and labels it | Feucht, Germany | Problems found, fixed voluntarilyOct 2022 |
| F.i.s. Fabbrica Italiana Sintetici S.p.a.Makes the active ingredient and tests it | Montecchio Maggiore, Italy | Problems found, fixed voluntarilyMar 2026 | |
| Ascend Laboratories, LLC150 mg, 500 mg · NDC 67877-458, 67877-459 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Aurobindo Pharma Limited150 mg, 500 mg · NDC 59651-204, 59651-205 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| BluePoint Laboratories.150 mg, 500 mg · NDC 68001-643, 68001-644 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Camber Pharmaceuticals Inc.150 mg, 500 mg · NDC 31722-774, 31722-775 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Caraco Pharmaceutical Laboratories, Ltd.150 mg, 500 mg · NDC 62756-238, 62756-239 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| CivicaScript LLC150 mg, 500 mg · NDC 82249-207, 82249-210 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Dr.Reddy's Laboratories Ltd.150 mg, 500 mg · NDC 55111-496, 55111-497 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Lifestar Pharma LLC.150 mg, 500 mg · NDC 70756-815, 70756-816 | Reliance Life Sciences Private LimitedMakes it, tests it, packages it and labels it | Navi Mumbai, India | Serious problems, FDA actionFeb 2026 |
| Northstar Rx LLC.500 mg · NDC 72603-303 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Novadoz Pharmaceuticals LLC150 mg, 500 mg · NDC 72205-006, 72205-007 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Quallent Pharmaceuticals Health LLC500 mg · NDC 82009-112 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Teyro Labs Private Limited150 mg, 500 mg · NDC 82511-001, 82511-002 | Teyro Labs Private LimitedMakes it, tests it and packages it | Kanchipuram District, India | Problems found, fixed voluntarilyNov 2025 |
| Areva Pharmaceuticals, Inc.150 mg, 500 mg · NDC 59923-721, 59923-722 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Armas Pharmaceuticals Inc.150 mg, 500 mg · NDC 72485-204, 72485-205 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pilnova Pharma Inc150 mg, 500 mg · NDC 83774-100, 83774-101 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prodigy Innovation, LLC.150 mg, 500 mg · NDC 70297-003, 70297-004 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.150 mg, 500 mg · NDC 0093-7473, 0093-7474 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Capecitabine 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.
- American Health Packaging:
60687-149 - Golden State Medical Supply, Inc.:
51407-639,51407-640 - Physicians Total Care, Inc.:
54868-4143,54868-5260 - State of Florida DOH Central Pharmacy:
53808-0411
Recalls
- Dec 21, 2015 · Class II · Teva North America
Failed Dissolution Specifications: low test results at the 18 month time-point
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.