Drug
Who makes tacrolimus?
35 companies list tacrolimus as a human prescription drug, including under the names Envarsus XR, Prograf. Forms: capsule; capsule, extended release; capsule, gelatin coated; granule, for suspension; injection; injection, solution; ointment; tablet, extended release. Routes: intravenous, oral, topical.
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 tacrolimus
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Astellas Pharma US, Inc.Japan | capsule, gelatin coated; granule, for suspension; injection, solution | NDANDA050708, NDA050709, NDA210115 | 6 | 8 |
| Bryant Ranch PrepackUnited States | capsule | ANDAANDA065461, ANDA091195 | 6 | 1 |
| Glenmark Pharmaceuticals Inc., USAIndia | capsule; ointment | ANDAANDA206662, ANDA210393 | 5 | 9 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | capsule; ointment | ANDAANDA091195, ANDA211688 | 5 | 2 |
| Dr. Reddy's Laboratories LimitedIndia | capsule | ANDAANDA090509 | 3 | 15 |
| Biocon Biologics LimitedIndia | capsule | ANDAANDA212297 | 3 | 9 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule | ANDAANDA090509 | 3 | 5 |
| Sandoz Industrial Products S.AAustria | capsule | ANDAANDA065461 | 3 | 5 |
| Strides Pharma Science LimitedIndia | capsule | ANDAANDA090687 | 3 | 5 |
| Concord Biotech LimitedIndia | capsule | ANDAANDA213112 | 3 | 3 |
| Safecor Health, LLCUnited States | capsule | ANDAANDA090596 | 3 | 3 |
| AJENAT PHARMACEUTICALS LLCUnited States | capsule | ANDAANDA206651 | 3 | 2 |
| BPI Labs, DBA Ally LabsUnited States | capsule | ANDAANDA206651 | 3 | 2 |
| Golden State Medical Supply Inc.United States | capsule | ANDAANDA090596 | 3 | 1 |
| PANACEA BIOTEC PHARMA LIMITEDIndia | capsule, gelatin coated | ANDAANDA090802 | 3 | 1 |
| ASCEND Therapeutics US, LLC | capsule | ANDAANDA203740 | 3 | 0 |
| Amneal Pharmaceuticals NY LLC | capsule, extended release | ANDAANDA215012 | 3 | 0 |
| Jubilant Cadista Pharmaceuticals Inc. | capsule, gelatin coated | ANDAANDA090802 | 3 | 0 |
| MAJOR Pharmaceuticals Inc. | capsule | ANDAANDA090509, ANDA090687 | 3 | 0 |
| Mylan Pharmaceuticals, Inc. | capsule | ANDAANDA090596 | 3 | 0 |
| MylanInstitutional Inc. | capsule | ANDAANDA090596 | 3 | 0 |
| Northstar Rx, LLC, | capsule | ANDAANDA206662 | 3 | 0 |
| Quallent Pharmaceuticals Health, LLC | capsule | ANDAANDA090509 | 3 | 0 |
| Stellon Biotech Inc. | capsule | ANDAANDA213112 | 3 | 0 |
| Veloxis Pharmaceuticals, Inc | tablet, extended release | NDANDA206406 | 3 | 0 |
| Cardinal Health 418, Inc.United States | capsule | ANDAANDA090687, ANDA212297 | 2 | 34 |
| International Medication Systems, Ltd.United States | capsule | ANDAANDA065461, ANDA206662 | 2 | 3 |
| Hangzhou Zhongmei Huadong Pharmaceutical Co., LtdChina | capsule | ANDAANDA210929 | 2 | 2 |
| Padagis Israel Pharmaceuticals LtdUnited States | ointment | NDANDA050777 | 2 | 2 |
| AvPAK | capsule | ANDAANDA090509 | 2 | 0 |
| E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | ointment | ANDAANDA200744 | 2 | 0 |
| Direct RxUnited States | capsule | ANDAANDA065461 | 1 | 1 |
| Nexus Pharmaceuticals, LLCUnited States | injection | ANDAANDA217108 | 1 | 1 |
| Proficient Rx LPUnited States | capsule | ANDAANDA065461 | 1 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | capsule | ANDAANDA090596 | 1 | 0 |
Bulk ingredient listings
- Concord Biotech LimitedIndia · 3 NDC
- Biocon Biologics LimitedIndia · 2 NDC
- Hangzhou Zhongmei Huadong Pharmaceutical Co., LtdChina · 2 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- CKD Bio CorporationSouth Korea · 1 NDC
- Chunghwa Chemical Synthesis & Biotech Co., Ltd. · 1 NDC
- Curia India Private LimitedItaly · 1 NDC
- Fishfa Biogenics · 1 NDC
- Hisun Pharmaceutical (Hangzhou) Co., Ltd. · 1 NDC
- JOYANG LABORATORIESChina · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- North China Pharmaceutical Huasheng Co. Ltd.China · 1 NDC
- Novartis Pharmaceuticals CorporationSwitzerland · 1 NDC
- Suresource Pharma LLCUnited States · 1 NDC
- TAPI Czech Industries s.r.o.Czechia · 1 NDC
- Teva Czech Industries s.r.o.Czechia · 1 NDC
- Wuxi Fortune Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
10 unexpired patents list tacrolimus as the active ingredient, expiring between May 2028 and Aug 2028. Application holder: VELOXIS PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes tacrolimus?
- 35 companies list tacrolimus as a human prescription drug in the openFDA NDC Directory, led by Astellas Pharma US, Inc., Bryant Ranch Prepack, Glenmark Pharmaceuticals Inc., USA, ACCORD HEALTHCARE LIMITED, Dr. Reddy's Laboratories Limited. 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 Envarsus XR?
- 32 companies list tacrolimus 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 tacrolimus active ingredient?
- 18 companies list tacrolimus as a bulk ingredient, including Concord Biotech Limited, Biocon Biologics Limited, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, AX Pharmaceutical Corp.