Drug
Who makes pyridostigmine bromide?
20 companies list pyridostigmine bromide as a human prescription drug, including under the names Mestinon, Regonol, Pryidostigmine Bromide. Forms: injection, solution; solution; tablet; tablet, extended release. Routes: intravenous, oral, parenteral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing pyridostigmine bromide
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bausch Health US, LLCCanada | solution; tablet; tablet, extended release | NDANDA009829, NDA011665, NDA015193 | 3 | 1 |
| Oceanside Pharmaceuticals. | solution; tablet; tablet, extended release | NDA AUTHORIZED GENERICNDA009829, NDA011665, NDA015193 | 3 | 0 |
| Amneal Pharmaceuticals of New York, LLCIndia | tablet | ANDAANDA040502 | 2 | 14 |
| Rising Pharma Holdings, Inc.United States | solution; tablet | ANDAANDA205464, ANDA208797 | 2 | 1 |
| Method Pharmaceuticals, LLC. | tablet | ANDAANDA211181 | 2 | 0 |
| Zydus Lifesciences LimitedIndia | tablet | ANDAANDA205650 | 1 | 12 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA040502 | 1 | 5 |
| Sandoz Industrial Products S.AAustria | injection, solution | NDANDA017398 | 1 | 5 |
| Apnar Pharma Private LimitedUnited States | solution | ANDAANDA208797 | 1 | 2 |
| ANI Pharmaceuticals, Inc.United States | tablet | ANDAANDA040512 | 1 | 1 |
| Acella Pharmaceuticals, LLCUnited States | solution | ANDAANDA212405 | 1 | 1 |
| Amneal Ireland LimitedIreland | tablet, extended release | NDANDA217604 | 1 | 1 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA205650 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet | ANDAANDA205650 | 1 | 1 |
| Alvogen, Inc. | tablet, extended release | ANDAANDA204737 | 1 | 0 |
| Amneal Pharmaceuticals NY LLC | solution | ANDAANDA212702 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA205650 | 1 | 0 |
| Novadoz Pharmaceuticals LLC | solution | ANDAANDA216512 | 1 | 0 |
| Surgeon General-Department of the Army (TSG-DA) | tablet | NDANDA020414 | 1 | 0 |
| VistaPharm, LLC | solution | ANDAANDA211694 | 1 | 0 |
Bulk ingredient listings
- Darmerica, LLCUnited States · 1 NDC
- Maithri Laboratories Private LimitedIndia · 1 NDC
- PROCOS SpAItaly · 1 NDC
- Patheon Austria GmbH & CoKG · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
Orange Book patents
9 unexpired patents list pyridostigmine bromide as the active ingredient, expiring between Jun 2038 and Jun 2038. Application holder: AMNEAL PHARMACEUTICALS LLC.
Enquiry
Common questions
- Who makes pyridostigmine bromide?
- 20 companies list pyridostigmine bromide as a human prescription drug in the openFDA NDC Directory, led by Bausch Health US, LLC, Oceanside Pharmaceuticals., Amneal Pharmaceuticals of New York, LLC, Rising Pharma Holdings, Inc., Method Pharmaceuticals, LLC.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Mestinon?
- 15 companies list pyridostigmine bromide under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies pyridostigmine bromide active ingredient?
- 5 companies list pyridostigmine bromide as a bulk ingredient, including Darmerica, LLC, Maithri Laboratories Private Limited, PROCOS SpA, Patheon Austria GmbH & CoKG.