Phosphodiesterase 5 Inhibitor
Where is Tadalafil made?
36 companies sell it under their own name and 22 repackagers rebottle it. Their labels name 30 factories in India, the United States and China.
India 20United States 6China 4
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Solco Healthcare U.S., LLC2.5 mg, 5 mg, 10 mg, 20 mg · NDC 43547-032, 43547-050, 43547-030 +6 | Generics Bidco II LLC d/b/a Prinston LaboratoriesMakes it | Charlotte, NC, United States | Problems found, fixed voluntarilySep 2025 |
| Zhejiang Huahai Pharmaceutical Co., Ltd.Makes it | Linhai, China | Serious problems, FDA actionApr 2026 | |
| Zhejiang Huahai Pharmaceutical Technology Co., Ltd.Makes it | Taizhou, China | Problems found, fixed voluntarilyAug 2025 | |
| Accord Healthcare Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 16729-371, 16729-369, 16729-372 +1 | Acme Generics Private LimitedMakes it and tests it | Solan, India | Problems found, fixed voluntarilyFeb 2026 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| Ajanta Pharma USA Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 27241-113, 27241-111, 27241-123 +2 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Ajanta Pharma LimitedMakes it | Bharuch, India | No problems foundJun 2023 | |
| Cipla USA., Inc.20 mg · NDC 69097-526 | Cipla LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyJun 2024 |
| SMS Pharmaceuticals LimitedMakes the active ingredient, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyMar 2025 | |
| Macleods Pharmaceuticals Limited2.5 mg, 5 mg, 10 mg, 20 mg · NDC 33342-267, 33342-265, 33342-278 +2 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Daman, India | Problems found, fixed voluntarilyMay 2023 | |
| Northstar Rx LLC.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 16714-076, 72603-783, 16714-074 +5 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Umedica Laboratories Private LimitedMakes it, tests it and packages it | Vapi, India | Problems found, fixed voluntarilyMar 2024 | |
| Torrent Pharma, Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 13668-567, 13668-565, 13668-568 +2 | Torrent Pharmaceuticals LimitedMakes it, makes the active ingredient, tests it and packages it | Indrad, India | Problems found, fixed voluntarilyJun 2024 |
| Torrent Pharmaceuticals LimitedMakes it, tests it and packages it | Bharuch, India | No problems foundJan 2026 | |
| ANI Pharmaceuticals, Inc.5 mg, 10 mg, 20 mg · NDC 70954-434, 70954-435, 70954-433 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Alembic Pharmaceuticals Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 62332-179, 62332-177, 62332-180 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited2.5 mg, 5 mg, 10 mg, 20 mg · NDC 46708-179, 46708-177, 46708-180 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals2.5 mg, 5 mg, 10 mg, 20 mg · NDC 60219-1348, 69238-1348, 60219-1346 +5 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Aurobindo Pharma Limited2.5 mg, 5 mg, 10 mg, 20 mg · NDC 65862-852, 65862-850, 65862-853 +2 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Bostal LLC2.5 mg, 5 mg, 10 mg, 20 mg · NDC 35561-256, 35561-254, 35561-257 +1 | Bostal LLCMakes it | Edison, NJ, United States | Problems found, fixed voluntarilyDec 2024 |
| Burel Pharmaceuticals, LLC2.5 mg, 5 mg, 10 mg, 20 mg · NDC 35573-462, 35573-460, 35573-463 +1 | VKT Pharma Private LimitedMakes it, tests it and packages it | Srikakulam, India | Problems found, fixed voluntarilyFeb 2025 |
| Cadila Healthcare Limited2.5 mg, 5 mg, 10 mg, 20 mg · NDC 70771-1477, 70771-1475, 70771-1478 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Camber Pharmaceuticals Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 31722-645, 31722-643, 31722-646 +2 | Hetero Labs LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 47335-011, 47335-009, 47335-012 +1 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Dr. Reddy's Laboratories Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 43598-574, 43598-576, 43598-578 +2 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Srikakulam, India | Problems found, fixed voluntarilyMay 2022 |
| Fourrts (india) Laboratories Private Limited2.5 mg, 5 mg, 10 mg, 20 mg · NDC 82968-003, 82968-001, 82968-005 +1 | Fourrts (india) Laboratories Private LimitedMakes it, tests it, packages it and labels it | Chennai, India | Not inspected on record |
| H.J. Harkins Co., Inc.5 mg, 10 mg, 20 mg · NDC 76519-1227, 76519-1225, 76519-1226 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| HEC Pharm USA Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 72303-0824, 72303-0822, 72303-0825 +1 | Sunshine Lake Pharma Co., Ltd.Makes it | Dongguan, China | Problems found, fixed voluntarilyMar 2024 |
| Lupin Pharmaceuticals, Inc.20 mg · NDC 68180-914 | Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 |
| Pharmaceutical Associates, Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 75834-249, 75834-247, 75834-250 +1 | Umedica Laboratories Private LimitedMakes it | Vapi, India | Problems found, fixed voluntarilyMar 2024 |
| Qilu Pharmaceutical Co., Ltd.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 67184-0525, 67184-0523, 67184-0526 +1 | Qilu Pharmaceutical (Hainan) Co., Ltd.Makes it, tests it and packages it | Haikou, China | Problems found, fixed voluntarilyMay 2023 |
| Quallent Pharmaceuticals Health LLC5 mg, 20 mg · NDC 82009-080, 82009-079, 82009-077 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Umedica Laboratories USA Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 60290-029, 60290-027, 60290-030 +1 | Umedica Laboratories Private LimitedMakes it, tests it and packages it | Vapi, India | Problems found, fixed voluntarilyMar 2024 |
| Upsher-Smith Laboratories, Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 24979-729, 24979-727, 24979-730 +1 | Qilu Pharmaceutical (Hainan) Co., Ltd.Makes it, tests it and packages it | Haikou, China | Problems found, fixed voluntarilyMay 2023 |
| VKT Pharma Private Limited2.5 mg, 5 mg, 10 mg, 20 mg · NDC 71821-008, 71821-006, 71821-009 +1 | VKT Pharma Private LimitedMakes it, tests it and packages it | Srikakulam, India | Problems found, fixed voluntarilyFeb 2025 |
| XLCare Pharmaceuticals, Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 72865-107, 72865-104, 72865-108 +1 | Evaric Pharmaceuticals IncMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2025 |
| Zydus Pharmaceuticals (USA) Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 68382-898, 68382-896, 68382-899 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| AvKARE, Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 42291-866, 42291-864, 73190-032 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| CMP Pharma, Inc. Tadliq20 mg per 5 mL · NDC 46287-045 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Eli Lilly and Company Cialis5 mg, 10 mg, 20 mg · NDC 0002-4463, 0002-4464, 0002-4462 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.5 mg, 10 mg, 20 mg · NDC 0480-2310, 0480-9277, 0480-2311 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 29300-288, 29300-286, 29300-289 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| United Therapeutics Corporation Adcirca20 mg · NDC 66302-467 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Tadalafil 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.
- A-S Medication Solutions:
50090-4247,50090-6150,50090-7152,50090-8039+12 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0443 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-581,71610-896,71610-908,71610-303+14 - Asclemed USA, Inc.:
76420-543,76420-553,76420-856,76420-542+11 - Bryant Ranch Prepack:
71335-1400,63629-8157,71335-2626,71335-1670+15 - Coupler LLC:
67046-1371 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-473 - Direct Rx:
61919-887,72189-145 - Dispensing Solutions Inc.:
66336-566 - Medsource Pharmaceuticals:
45865-991,45865-218 - Northwind Pharmaceuticals:
82868-028,51655-063,51655-473,51655-487 - NuCare Pharmaceuticals.Inc.:
68071-2613,68071-3601,68071-2554,68071-3758+17 - PD-Rx Pharmaceuticals, Inc.:
72789-430,72789-184,72789-408,72789-396+3 - Physicians Total Care, Inc.:
54868-4665,54868-4968,54868-5956 - Preferred Pharmaceuticals, Inc..:
68788-8153,68788-4083,68788-8445,68788-8664+3 - Proficient Rx LP:
71205-418,71205-502,71205-720,71205-735+10 - Rebel Distributors Corp..:
21695-028,21695-029 - RedPharm Drug. Inc.:
67296-2237 - Remedyrepack Inc.:
70518-3931,70518-4534,70518-4549,70518-4605+3 - Stat Rx USA:
16590-905 - Unit Dose Services:
50436-4463,50436-0645,50436-7001,50436-4465+10 - Unyter Enterprises:
71455-597
Recalls
- Mar 23, 2023 · Class II · Preferred Pharmaceuticals, Inc.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. - Mar 16, 2023 · Class II · Northwind Pharmaceuticals LLC · 2 recall notices
CGMP Deviations - Feb 7, 2023 · Class II · Accord Healthcare, Inc. · 4 recall notices
CGMP Deviations: recalling drug products following an FDA inspection. - Oct 25, 2021 · Class II · Sun Pharmaceutical Industries Inc · 2 recall notices
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.