Prescription drug
Where is Glatiramer made?
8 companies sell it under their own name and 1 repackager rebottle it. Their labels name 4 factories in China, the United States, Italy and Taiwan.
China 1United States 1Italy 1Taiwan 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Ajenat Pharmaceuticals LLC20 mg per 1 mL, 40 mg per 1 mL · NDC 82983-429, 82983-430 | Guangdong Sunshine Pharmaceutical Co LtdMakes it and tests it | Dongguan, China | Not inspected on record |
| Caraco Pharmaceutical Laboratories, Ltd.20 mg per 1 mL, 40 mg per 1 mL · NDC 47335-990, 47335-991 | Catalent Indiana, LLCMakes it and tests it | Bloomington, IN, United States | Serious problems, FDA actionApr 2026 |
| Italfarmaco S.p.A20 mg per 1 mL, 40 mg per 1 mL · NDC 11797-764, 11797-765 | Italfarmaco SPAMakes it, tests it and packages it | Milan, Italy | Problems found, fixed voluntarilyJun 2023 |
| Upsher-Smith Laboratories, Inc.20 mg per 1 mL, 40 mg per 1 mL · NDC 0832-6084, 0832-6085 | ScinoPharm Taiwan, Ltd.Makes it, makes the active ingredient, tests it and packages it | Tainan, Taiwan | Serious problems, FDA actionJun 2026 |
| Zydus Pharmaceuticals (USA) Inc.20 mg per 1 mL, 40 mg per 1 mL · NDC 70710-1548, 70710-1549 | Italfarmaco SPAMakes it, tests it, packages it and labels it | Milan, Italy | Problems found, fixed voluntarilyJun 2023 |
| Mylan Pharmaceuticals Inc.20 mg per 1 mL, 40 mg per 1 mL · NDC 0378-6960, 0378-6961 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.20 mg per 1 mL, 40 mg per 1 mL · NDC 0781-3234, 0781-3250 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Neuroscience, Inc. Copaxone20 mg per 1 mL, 40 mg per 1 mL · NDC 68546-317, 68546-325 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Glatiramer 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:
63629-8815,63629-8816
Recalls
- Oct 24, 2013 · Class II · Teva Pharmaceuticals USA
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe. - Dec 5, 2012 · Class II · Teva Pharmaceuticals USA, Inc.
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system. - May 18, 2012 · Class II · Teva Pharmaceuticals USA, Inc.
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.