Drug
Who makes mycophenolate mofetil?
36 companies list mycophenolate mofetil as a human prescription drug, including under the names CellCept, MYHIBBIN. Forms: capsule; injection, powder, lyophilized, for solution; powder, for suspension; suspension; tablet; tablet, film coated. Routes: intravenous, 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 mycophenolate mofetil
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Strides Pharma Science LimitedIndia | capsule; powder, for suspension; tablet, film coated | ANDAANDA090055, ANDA090456, ANDA212634 | 5 | 5 |
| RemedyRepack, IncUnited States | capsule; tablet, film coated | ANDAANDA090055, ANDA090456, ANDA210181 | 4 | 1 |
| Genentech, Inc.United States | capsule; powder, for suspension; tablet, film coated | NDANDA050722, NDA050723, NDA050759 | 3 | 8 |
| Aurobindo Pharma LimitedIndia | capsule; powder, for suspension; tablet, film coated | ANDAANDA217828, ANDA217937, ANDA218227 | 3 | 6 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | capsule; powder, for suspension; tablet, film coated | ANDAANDA090055, ANDA090456, ANDA212634 | 3 | 1 |
| ASCEND Therapeutics US, LLC | capsule; powder, for suspension; tablet, film coated | ANDAANDA091249, ANDA200197, ANDA203005 | 3 | 0 |
| Cardinal Health 418, Inc.United States | capsule; tablet, film coated | ANDAANDA090456, ANDA200197 | 2 | 34 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule; tablet, film coated | ANDAANDA090456, ANDA200197 | 2 | 5 |
| Sandoz Industrial Products S.AAustria | capsule; tablet, film coated | ANDAANDA065379, ANDA065451 | 2 | 5 |
| Concord Biotech LimitedIndia | capsule; tablet | ANDAANDA210181, ANDA212087 | 2 | 3 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | capsule; tablet | ANDAANDA065416, ANDA090253 | 2 | 2 |
| Camber Pharmaceuticals, Inc.United States | capsule; tablet, film coated | ANDAANDA207022, ANDA208119 | 2 | 1 |
| Advagen Pharma Limited | capsule; tablet | ANDAANDA210181, ANDA212087 | 2 | 0 |
| AvKARE | capsule; tablet, film coated | ANDAANDA090055, ANDA090456 | 2 | 0 |
| AvPAK | capsule; tablet, film coated | ANDAANDA091249, ANDA200197 | 2 | 0 |
| MAJOR Pharmaceuticals Inc. | capsule; tablet, film coated | ANDAANDA090456, ANDA200197 | 2 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule | ANDAANDA065491 | 1 | 6 |
| Par Health USA, LLCIndia | injection, powder, lyophilized, for solution | ANDAANDA203575 | 1 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | tablet | ANDAANDA065413 | 1 | 4 |
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA091249 | 1 | 3 |
| ONESOURCE SPECIALTY PHARMA LIMITEDIndia | injection, powder, lyophilized, for solution | ANDAANDA216390 | 1 | 3 |
| QUAGEN PHARMACEUTICALS LLCUnited States | powder, for suspension | ANDAANDA214525 | 1 | 2 |
| Amneal Ireland LimitedIreland | powder, for suspension | ANDAANDA214871 | 1 | 1 |
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA065416 | 1 | 1 |
| Lannett Company, LLCUnited States | powder, for suspension | ANDAANDA214525 | 1 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet, film coated | ANDAANDA090456 | 1 | 1 |
| Proficient Rx LPUnited States | tablet, film coated | ANDAANDA090456 | 1 | 1 |
| Wuxi Fortune Pharmaceutical Co., Ltd.China | capsule | ANDAANDA214079 | 1 | 1 |
| Amneal Pharmaceuticals NY LLC | powder, for suspension | ANDAANDA214871 | 1 | 0 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, film coated | ANDAANDA065521 | 1 | 0 |
| Armas Pharmaceuticals, Inc. | injection, powder, lyophilized, for solution | ANDAANDA216390 | 1 | 0 |
| Azurity Pharmaceuticals, Inc. | suspension | NDANDA216482 | 1 | 0 |
| Meitheal Pharmaceuticals, Inc. | injection, powder, lyophilized, for solution | ANDAANDA212130 | 1 | 0 |
| Mylan Institutional Inc. | injection, powder, lyophilized, for solution | ANDAANDA203859 | 1 | 0 |
| Northstar Rx, LLC, | powder, for suspension | ANDAANDA218227 | 1 | 0 |
| VistaPharm, LLC | powder, for suspension | ANDAANDA210370 | 1 | 0 |
Bulk ingredient listings
- Concord Biotech LimitedIndia · 4 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Biocon Biologics LimitedIndia · 1 NDC
- CKD Bio CorporationSouth Korea · 1 NDC
- Chunghwa Chemical Synthesis & Biotech Co., Ltd. · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Dasami Lab Private LimitedIndia · 1 NDC
- Emcure Pharmaceuticals LimitedIndia · 1 NDC
- Excella GmbH & Co. KGGermany · 1 NDC
- Formosa Laboratories, Inc.Taiwan · 1 NDC
- Novartis Pharmaceuticals CorporationSwitzerland · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- RAKSHIT DRUGS PRIVATE LIMITEDIndia · 1 NDC
- SOLARA ACTIVE PHARMA SCIENCES LIMITEDIndia · 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
5 unexpired patents list mycophenolate mofetil as the active ingredient, expiring between Aug 2039 and Aug 2039. Application holder: AZURITY PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes mycophenolate mofetil?
- 36 companies list mycophenolate mofetil as a human prescription drug in the openFDA NDC Directory, led by Strides Pharma Science Limited, RemedyRepack, Inc, Genentech, Inc., Aurobindo Pharma Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. 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 CellCept?
- 34 companies list mycophenolate mofetil under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies mycophenolate mofetil active ingredient?
- 17 companies list mycophenolate mofetil as a bulk ingredient, including Concord Biotech Limited, AX Pharmaceutical Corp, Biocon Biologics Limited, CKD Bio Corporation.