Cholinergic Receptor Agonist
Where is Pilocarpine made?
12 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 6 factories in India and the United States.
India 4United States 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals5 mg, 7.5 mg, 10 mg per 1 mL, 12.5 mg per 1 mL, 20 mg per 1 mL, 40 mg per 1 mL · NDC 69238-1745, 60219-2366, 60219-2649 +5 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| Amneal Pharmaceuticals of New York, LLCMakes it, tests it and packages it | Brookhaven, NY, United States | No problems foundSep 2026 | |
| Akorn10 mg per 1 mL, 20 mg per 1 mL, 40 mg per 1 mL · NDC 17478-223, 17478-224, 17478-226 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Aurobindo Pharma Limited5 mg, 7.5 mg · NDC 59651-224, 59651-225 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Lannett Company, Inc.5 mg, 7.5 mg · NDC 0527-1313, 0527-1407 | Lannett Company, LLCMakes it, tests it, packages it and labels it | Seymour, IN, United States | Problems found, fixed voluntarilyOct 2022 |
| Leading Pharma, LLC10 mg per 1 mL, 20 mg per 1 mL, 40 mg per 1 mL · NDC 69315-314, 69315-315, 69315-316 | FDC LimitedMakes it | Chhatrapati Sambhajinagar, India | No problems foundFeb 2023 |
| Somerset Therapeutics, LLC10 mg per 1 mL, 20 mg per 1 mL, 40 mg per 1 mL · NDC 70069-181, 70069-191, 70069-201 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Actavis Pharma, Inc.5 mg, 7.5 mg · NDC 0228-2801, 0228-2837 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Advanz Pharma (US) Corp. Salagen5 mg, 7.5 mg · NDC 59212-705, 59212-775 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amici Pharmaceuticals, LLC.5 mg · NDC 69292-265 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.5 mg, 7.5 mg · NDC 10135-589, 10135-590 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Orasis Pharmaceuticals, Inc. Qlosi4 mg per 1 mL · NDC 83661-018 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.10 mg per 1 mL, 20 mg per 1 mL, 40 mg per 1 mL · NDC 61314-203, 61314-204, 61314-206 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Pilocarpine 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:
68084-928 - AvPAK:
50268-652 - Bryant Ranch Prepack:
63629-8351,72162-1078,63629-2099 - Carilion Materials Management:
68151-3015 - Marlex Pharmaceuticals, Inc.:
10135-680 - Physicians Total Care, Inc.:
54868-5436 - Rebel Distributors Corp..:
21695-368,21695-601
Recalls
- Mar 22, 2017 · Class III · Novartis Pharmaceuticals Corp.
Failed Impurities/Degradation Specifications.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.