Prescription drug
Where is Monomethyl made?
21 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 14 factories in India, Taiwan and the United States.
India 11Taiwan 2United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cipla USA., Inc.120 mg, 120 mg / 240 mg, 240 mg · NDC 69097-322, 69097-552, 69097-323 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| MSN Organics Private LimitedMakes the active ingredient and tests it | Yadadri Bhuvanagiri District, India | Problems found, fixed voluntarilyMar 2023 | |
| Upsher-Smith Laboratories, Inc.120 mg, 240 mg · NDC 24979-127, 24979-128 | Bora Pharmaceutical Laboratories Inc. Zhongli PlantMakes it and packages it | Taoyuan City, Taiwan | Problems found, fixed voluntarilyFeb 2020 |
| Bora Pharmaceutical Laboratories Inc. Zhongli Plant Building IIMakes it, tests it and packages it | Taoyuan City, Taiwan | Problems found, fixed voluntarilyFeb 2020 | |
| Accord Healthcare Inc.120 mg, 120 mg / 240 mg, 240 mg · NDC 16729-416, 16729-418, 16729-417 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals120 mg, 120 mg / 240 mg, 240 mg · NDC 69238-1318, 69238-1626, 69238-1319 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Ascend Laboratories, LLC120 mg, 120 mg / 240 mg, 240 mg · NDC 67877-555, 67877-557, 67877-556 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Aurobindo Pharma Limited120 mg, 240 mg · NDC 59651-083, 59651-084 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Banner Life Sciences LLC. Bafiertam95 mg · NDC 69387-001 | Patheon Softgels Inc.Makes it | High Point, NC, United States | Problems found, fixed voluntarilyJul 2025 |
| Cadila Healthcare Limited120 mg, 120 mg / 240 mg, 240 mg · NDC 70771-1530, 70771-1532, 70771-1531 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Camber Pharmaceuticals Inc.120 mg, 120 mg / 240 mg, 240 mg · NDC 31722-657, 31722-680, 31722-658 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| CivicaScript LLC120 mg, 240 mg · NDC 82249-745, 82249-747 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Dr. Reddy's Laboratories Inc.120 mg, 240 mg · NDC 43598-429, 43598-430 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Glenmark Pharmaceuticals Inc., USA120 mg, 120 mg / 240 mg, 240 mg · NDC 68462-307, 68462-570, 68462-308 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Lupin Pharmaceuticals, Inc.120 mg, 120 mg / 240 mg, 240 mg · NDC 68180-776, 68180-778, 68180-777 | Aizant Drug Research Solutions PVT LtdMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2026 |
| MSN Laboratories Private Limited120 mg, 120 mg / 240 mg, 240 mg · NDC 69539-042, 69539-240, 69539-043 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Macleods Pharmaceuticals Limited120 mg, 120 mg / 240 mg, 240 mg · NDC 33342-349, 33342-351, 33342-579 +1 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Quallent Pharmaceuticals Health LLC240 mg · NDC 82009-138 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Zydus Pharmaceuticals (USA) Inc.120 mg, 120 mg / 240 mg, 240 mg · NDC 70710-1204, 70710-1416, 70710-1205 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Biogen MA Inc. Tecfidera, Vumerity120 mg, 120 mg / 240 mg, 231 mg, 240 mg · NDC 64406-005, 64406-007, 64406-020 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.120 mg, 240 mg · NDC 0378-0396, 0378-0399 | The label doesn't name the factory. Plants this company names for other drugs | ||
| SOLA Pharmaceuticals, LLC120 mg, 240 mg · NDC 70512-852, 70512-853 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Solco Healthcare U.S., LLC120 mg, 240 mg · NDC 43547-024, 43547-025 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Monomethyl 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.
- A-S Medication Solutions:
50090-5288 - Golden State Medical Supply, Inc.:
51407-442,84677-029,51407-441,84677-030
Recalls
- Dec 9, 2020 · Class II · Biogen MA Inc.
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing. - Jun 23, 2020 · Class III · Biogen MA Inc.
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.