Corticosteroid, Polyene Antifungal
Where is Nystatin and Triamcinolone Acetonide made?
13 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 11 factories in India, the United States, Canada and Israel.
India 7United States 2Canada 1Israel 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd.1 mg per 1 g / 100000 [USP'U] per 1 g · NDC 51672-1272, 51672-1263 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 | |
| Alembic Pharmaceuticals Inc.1 mg per 1 g / 100000 [USP'U] per 1 g · NDC 62332-606, 62332-585 | Alembic Pharmaceuticals LimitedMakes it and tests it | Vadodara, India | No problems foundMar 2023 |
| Alembic Pharmaceuticals Limited1 mg per 1 g / 100000 [USP'U] per 1 g · NDC 46708-606 | Alembic Pharmaceuticals LimitedMakes it and tests it | Vadodara, India | No problems foundMar 2023 |
| Cadila Healthcare Limited1 mg per 1 g / 100000 [USP'U] per 1 g · NDC 70771-1447 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Crown Laboratories1 mg per 1 g / 100000 [USP'U] per 1 g · NDC 0316-0223 | Crown LaboratoriesMakes it | Johnson City, TN, United States | Problems found, fixed voluntarilySep 2025 |
| Encube Ethicals, Inc.1 mg per 1 g / 100000 [USP'U] per 1 g · NDC 21922-031 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Glenmark Pharmaceuticals Inc., USA1 mg per 1 g / 100000 [USP'U] per 1 g · NDC 68462-799 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Solan, India | Serious problems, FDA actionJun 2022 |
| Lupin Pharmaceuticals, Inc.1 mg per 1 g / 100000 [USP'U] per 1 g · NDC 68180-545 | Lupin LimitedMakes it and packages it | Pithampur, India | Problems found, fixed voluntarilyJul 2025 |
| Macleods Pharmaceuticals Limited1 mg per 1 g / 100000 [USP'U] per 1 g · NDC 33342-483, 33342-482 | Oxalis LabsMakes it, tests it, packages it and labels it | Solan, India | Problems found, fixed voluntarilyJun 2023 |
| Teligent Pharma, Inc.1 mg per 1 g / 100000 [USP'U] per 1 g · NDC 52565-042 | Teligent Pharma, Inc.Makes it | Buena, New Jersey, United States | Serious problems, FDA actionAug 2021 |
| Torrent Pharmaceuticals Limited1 mg per 1 g / 100000 [USP'U] per 1 g · NDC 13668-610 | Torrent Pharmaceuticals LimitedMakes it, tests it and packages it | Pithampur, India | Problems found, fixed voluntarilyOct 2019 |
| Viona Pharmaceuticals Inc.1 mg per 1 g / 100000 [USP'U] per 1 g · NDC 72578-088 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Padagis Israel Pharmaceuticals Ltd1 mg per 1 g / 100000 [USP'U] per 1 g · NDC 45802-880, 45802-244 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Nystatin and Triamcinolone Acetonide 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:
72162-1403,63629-8688,63629-2497,63629-2495+8 - Central Texas Community Health Centers:
76413-120 - NuCare Pharmaceuticals.Inc.:
68071-3510,68071-5037,68071-2491,68071-3972 - Preferred Pharmaceuticals, Inc..:
68788-8808,68788-8662,68788-8245 - RPK Pharmaceuticals, Inc.:
53002-9360,53002-9361 - RedPharm Drug. Inc.:
67296-1684 - Remedyrepack Inc.:
70518-1114
Recalls
- Mar 15, 2022 · Class II · Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Jul 17, 2019 · Class III · Lupin Pharmaceuticals Inc.
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation. - Mar 28, 2017 · Class II · Taro Pharmaceuticals U.S.A., Inc.
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.