Phosphodiesterase 4 Inhibitor
Where is Roflumilast made?
15 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 9 factories in India, the United States and China.
India 6United States 2China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Novadoz Pharmaceuticals LLC250 ug, 500 ug · NDC 72205-201, 72205-200 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 | |
| Ascend Laboratories, LLC250 ug, 500 ug · NDC 67877-730, 67877-480 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Aurobindo Pharma Limited250 ug, 500 ug · NDC 59651-801, 59651-275 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Cadila Healthcare Limited250 ug, 500 ug · NDC 70771-1673, 70771-1674 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Camber Pharmaceuticals Inc.250 ug, 500 ug · NDC 31722-676, 31722-623 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Jubilant Cadista Pharmaceuticals Inc.250 ug, 500 ug · NDC 59746-801, 59746-802 | Havix Group Inc d/b/a Aavis PharmaceuticalsMakes it | Hoschton, GA, United States | Problems found, fixed voluntarilyJul 2025 |
| Major Pharmaceuticals250 ug, 500 ug · NDC 0904-7493, 0904-7399 | MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 |
| Micro Labs Limited250 ug, 500 ug · NDC 42571-369, 42571-259 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| Solco Healthcare U.S., LLC500 ug · NDC 43547-005 | Zhejiang Huahai Pharmaceutical Co., Ltd.Makes it | Linhai, China | Serious problems, FDA actionApr 2026 |
| Zydus Pharmaceuticals (USA) Inc.250 ug, 500 ug · NDC 68382-624, 68382-969 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Amici Pharma Inc.250 ug, 500 ug · NDC 69292-630, 69292-631 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Arcutis Biotherapeutics, Inc. Zoryve0.5 mg per 1 g, 1.5 mg per 1 g, 3 mg per 1 g · NDC 80610-105, 80610-115, 80610-130 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AstraZeneca Pharmaceuticals LP Daliresp250 ug, 500 ug · NDC 0310-0088, 0310-0095 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.250 ug, 500 ug · NDC 73190-086, 73190-087 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Strides Pharma Science Limited250 ug, 500 ug · NDC 64380-287, 64380-786 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Roflumilast 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:
60687-786 - Bryant Ranch Prepack:
72162-2385 - Golden State Medical Supply, Inc.:
51407-975 - Major Pharmaceuticals:
0904-7483