Atypical Antipsychotic
Where is Asenapine made?
7 companies sell it under their own name and 1 repackager rebottle it. Their labels name 5 factories in India, Japan and the United States.
India 3Japan 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Breckenridge Pharmaceutical, Inc.2.5 mg, 5 mg, 10 mg · NDC 51991-361, 51991-360, 51991-928 +2 | Centaur Pharmaceuticals Private LimitedMakes it | Pune, India | Serious problems, FDA actionFeb 2023 |
| MSN Laboratories Private LimitedMakes it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 | |
| Alembic Pharmaceuticals Inc.2.5 mg, 5 mg, 10 mg · NDC 62332-199, 62332-544, 62332-198 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited2.5 mg, 5 mg, 10 mg · NDC 46708-199, 46708-544, 46708-198 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| MSN Laboratories Private Limited2.5 mg, 5 mg, 10 mg · NDC 69539-059, 69539-060, 69539-245 +2 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Noven Therapeutics, LLC Secuado3.8 mg per 1 d, 5.7 mg per 1 d, 7.6 mg per 1 d · NDC 68968-0172, 68968-0173, 68968-0174 | Hisamitsu Pharmaceutical Co., Inc.Makes it | Tosu, Japan | Problems found, fixed voluntarilyJul 2025 |
| SigmaPharm Laboratories, LLC5 mg, 10 mg · NDC 42794-017, 42794-016 | Sigmapharm Laboratories, LLCMakes it and tests it | Bensalem, PA, United States | Problems found, fixed voluntarilyDec 2025 |
| Allergan, Inc. Saphris2.5 mg, 5 mg, 10 mg · NDC 0456-2410, 0456-2402, 0456-2405 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Asenapine 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.
- Stat Rx USA:
16590-936
Recalls
- Apr 19, 2021 · Class III · SigmaPharm Laboratories LLC · 2 recall notices
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent - May 18, 2017 · Class II · Forest Laboratories, LLC
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.