Drug
Who makes tadalafil?
48 companies list tadalafil as a human prescription drug, including under the names ADCIRCA, Cialis, TADLIQ, ALYQ. Forms: suspension; tablet; tablet, coated; tablet, film coated. Routes: oral.
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 tadalafil
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| NuCare Pharmaceuticals,Inc.United States | tablet; tablet, film coated | ANDAANDA209167, ANDA209250, ANDA209654 | 18 | 1 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet; tablet, film coated | ANDAANDA207244, ANDA208934, ANDA209167 | 15 | 1 |
| Bryant Ranch PrepackUnited States | tablet; tablet, film coated | ANDAANDA208934, ANDA209167, ANDA209250 | 15 | 1 |
| Proficient Rx LPUnited States | tablet; tablet, film coated | ANDAANDA209167, ANDA209250, ANDA209654 | 13 | 1 |
| International Medication Systems, Ltd.United States | tablet; tablet, film coated | ANDAANDA208934, ANDA209167, ANDA209654 | 11 | 3 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet; tablet, film coated | ANDA, UNAPPROVED DRUG OTHERANDA209654, ANDA209744, ANDA210609 | 9 | 0 |
| Solco healthcare U.S., LLC | tablet | ANDAANDA210608, ANDA210609 | 9 | 0 |
| Alembic Pharmaceuticals LimitedIndia | tablet, coated | ANDAANDA204809 | 8 | 7 |
| Amneal Pharmaceuticals NY LLC | tablet, film coated | ANDAANDA209744 | 8 | 0 |
| PD-Rx Pharmaceuticals Inc.United States | tablet; tablet, film coated | ANDAANDA209654, ANDA211298, ANDA215556 | 7 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet; tablet, film coated | ANDAANDA209167, ANDA209250, ANDA209654 | 7 | 1 |
| RemedyRepack, IncUnited States | tablet; tablet, film coated | ANDAANDA207244, ANDA209654, ANDA210608 | 6 | 1 |
| Macleods Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA207244, ANDA207290 | 5 | 5 |
| Torrent Pharma, Inc.India | tablet | ANDAANDA211839, ANDA212062 | 5 | 5 |
| Ajanta Pharma LimitedIndia | tablet | ANDAANDA209654, ANDA210392 | 5 | 2 |
| Camber Pharmaceuticals, Inc.United States | tablet; tablet, film coated | ANDAANDA209907, ANDA209908 | 5 | 1 |
| AvKARE | tablet; tablet, film coated | ANDAANDA209744, ANDA210608 | 5 | 0 |
| Dr. Reddys Laboratories Limited | tablet, film coated | ANDAANDA210069, ANDA210145 | 5 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated | ANDAANDA208934 | 4 | 13 |
| Zydus Lifesciences LimitedIndia | tablet, film coated | ANDAANDA206693 | 4 | 12 |
| Qilu Pharmaceutical Co., Ltd.China | tablet, film coated | ANDAANDA210420 | 4 | 5 |
| Unichem Laboratories Limited, IndiaIndia | tablet, film coated | ANDAANDA209250 | 4 | 5 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet, film coated | ANDAANDA209167 | 4 | 2 |
| HEC Pharm USA Inc.China | tablet, film coated | ANDAANDA211335 | 4 | 2 |
| Nivagen Pharmaceuticals LLCUnited States | tablet, film coated | ANDAANDA211298 | 4 | 2 |
| Bostal LLCUnited States | tablet, film coated | ANDAANDA208824 | 4 | 1 |
| FOURRTS INDIA LABORATORIES PRIVATE LIMITEDIndia | tablet, film coated | ANDAANDA217606 | 4 | 1 |
| Northwind Health Company, LLCUnited States | tablet; tablet, film coated | ANDAANDA206286, ANDA206693, ANDA209167 | 4 | 1 |
| UMEDICA LABORATORIES PRIVATE LIMITEDIndia | tablet, film coated | ANDAANDA211298 | 4 | 1 |
| VKT Pharma Private LimitedIndia | tablet, film coated | ANDAANDA215556 | 4 | 1 |
| XLCare Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA209908 | 4 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet, film coated | ANDAANDA206693 | 4 | 1 |
| Burel Pharmaceuticals, LLC | tablet, film coated | ANDAANDA215556 | 4 | 0 |
| NorthStar RxLLC | tablet, film coated | ANDAANDA208934 | 4 | 0 |
| Northstar Rx, LLC, | tablet, film coated | ANDAANDA211298 | 4 | 0 |
| Upsher-Smith Laboratories, Inc. | tablet, film coated | ANDAANDA210420 | 4 | 0 |
| Eli Lilly and CompanyUnited States | tablet, film coated | NDANDA021368 | 3 | 10 |
| Aurobindo Pharma LimitedIndia | tablet; tablet, film coated | ANDAANDA206285, ANDA206286 | 3 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet, film coated | ANDAANDA205885, ANDA216932 | 3 | 6 |
| ANI Pharmaceuticals, Inc.United States | tablet | ANDAANDA215949 | 3 | 1 |
| Quallent Pharmaceuticals Health, LLC | tablet | ANDAANDA209654, ANDA210392 | 3 | 0 |
| Lupin LimitedIndia | tablet, film coated | ANDAANDA210572 | 1 | 14 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | tablet, film coated | ANDAANDA210255 | 1 | 7 |
| United Therapeutics CorporationUnited States | tablet | NDANDA022332 | 1 | 4 |
| CMP Pharma, Inc.United States | suspension | NDANDA214522 | 1 | 1 |
| Direct RxUnited States | tablet | ANDAANDA209654 | 1 | 1 |
| RedPharm DrugUnited States | tablet, film coated | ANDAANDA209250 | 1 | 1 |
| Advanced Rx of Tennessee, LLC | tablet, film coated | ANDAANDA210420 | 1 | 0 |
Bulk ingredient listings
- AX Pharmaceutical CorpCanada · 2 NDC
- Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)India · 2 NDC
- SMS Pharmaceuticals LimitedIndia · 2 NDC
- AZICO BIOPHORE INDIA PRIVATE LIMITEDIndia · 1 NDC
- Alivus Life Sciences Limited · 1 NDC
- Ami Lifesciences Private LimitedIndia · 1 NDC
- Assia Chemical Industries Ltd. - Teva Tech SiteIsrael · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Aurore Pharmaceuticals Private LimitedIndia · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Evonik Operations GmbHGermany · 1 NDC
- Galenova IncCanada · 1 NDC
- HORSTER BIOTEK PRIVATE LIMITEDIndia · 1 NDC
- HORSTER LIFE SCIENCE PVT LTDIndia · 1 NDC
- Honour Lab LimitedIndia · 1 NDC
- Jubilant Pharmova Limited · 1 NDC
- Kalchem International Inc.United States · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- MSN Organics Private LimitedIndia · 1 NDC
- Pharma Source Direct, LLCUnited States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- SCH Global Services Private Limited · 1 NDC
- SHOOLIN PHARMA CHEM LLPIndia · 1 NDC
- SRINI PHARMACEUTICALS PRIVATE LIMITEDIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Synergene Active Ingredients Private LimitedIndia · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
- XENEX LABORATORIES INCCanada · 1 NDC
- ZAKLADY FARMACEUTYCZNE POLPHARMA S APoland · 1 NDC
- Zhejiang Bamboo Pharmaceuticals Co.,LtdChina · 1 NDC
- Zhejiang Huahai Pharmaceutical Technology Co LtdChina · 1 NDC
Orange Book patents
8 unexpired patents list tadalafil as the active ingredient, expiring between Dec 2038 and Dec 2038. Application holder: CMP DEVELOPMENT LLC.
Enquiry
Common questions
- Who makes tadalafil?
- 48 companies list tadalafil as a human prescription drug in the openFDA NDC Directory, led by NuCare Pharmaceuticals,Inc., ASCLEMED USA INC. DBA ENOVACHEM, Bryant Ranch Prepack, Proficient Rx LP, International Medication Systems, Ltd.. 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 ADCIRCA?
- 45 companies list tadalafil under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies tadalafil active ingredient?
- 32 companies list tadalafil as a bulk ingredient, including AX Pharmaceutical Corp, Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.), SMS Pharmaceuticals Limited, AZICO BIOPHORE INDIA PRIVATE LIMITED.