Drug
Who makes mesalamine?
36 companies list mesalamine as a human prescription drug, including under the names APRISO, Canasa, Lialda, Pentasa, Rowasa. Forms: capsule; capsule, delayed release; capsule, extended release; enema; kit; suppository; suspension; tablet, delayed release. Routes: oral, rectal.
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 mesalamine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | kit; suppository; suspension; tablet, delayed release | ANDAANDA076751, ANDA203817, ANDA207448 | 7 | 1 |
| Zydus Lifesciences LimitedIndia | capsule, extended release; suppository; tablet, delayed release | ANDAANDA091640, ANDA203286, ANDA208953 | 4 | 12 |
| Takeda Pharmaceuticals U.S.A., Inc.Germany | capsule; tablet, delayed release | NDA, NDA AUTHORIZED GENERICNDA020049, NDA022000 | 4 | 7 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule, delayed release; capsule, extended release; tablet, delayed release | ANDAANDA091640, ANDA203286, ANDA207873 | 4 | 5 |
| Zydus Pharmaceuticals USA Inc.India | capsule, extended release; suppository; tablet, delayed release | ANDAANDA091640, ANDA203286, ANDA208953 | 4 | 1 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule, delayed release; capsule, extended release; tablet, delayed release | ANDA, NDA AUTHORIZED GENERICANDA207873, ANDA213191, NDA022301 | 3 | 6 |
| Padagis Israel Pharmaceuticals LtdUnited States | enema; kit | ANDAANDA076751 | 3 | 2 |
| Camber Pharmaceuticals, Inc.United States | capsule, extended release; suppository; tablet, delayed release | ANDAANDA213377, ANDA216334, ANDA219864 | 3 | 1 |
| Sun Pharmaceutical Industries LimitedIndia | capsule, extended release; tablet, delayed release | ANDAANDA211858, ANDA214585 | 2 | 13 |
| Alembic Pharmaceuticals LimitedIndia | capsule, extended release | ANDAANDA216967 | 2 | 7 |
| Sandoz Industrial Products S.AAustria | capsule, extended release | ANDAANDA219997 | 2 | 5 |
| ANI Pharmaceuticals, Inc.United States | enema; suspension | ANDA, NDA AUTHORIZED GENERICANDA215269, NDA019618 | 2 | 1 |
| Actavis LLCUnited States | suppository; tablet, delayed release | ANDAANDA203817, ANDA205654 | 2 | 1 |
| Golden State Medical Supply Inc.United States | capsule, extended release; tablet, delayed release | ANDAANDA091640, ANDA217533 | 2 | 1 |
| Rising Pharma Holdings, Inc.United States | suppository | ANDAANDA207448, ANDA219028 | 2 | 1 |
| Viatris Inc.India | suspension | NDANDA019618 | 1 | 18 |
| Allergan, Inc.United States | suppository | NDANDA021252 | 1 | 7 |
| Aurobindo Pharma LimitedIndia | capsule, extended release | ANDAANDA214477 | 1 | 6 |
| Encube Ethicals LimitedIndia | suspension | ANDAANDA216941 | 1 | 5 |
| KLM Laboratories Private LimitedIndia | suspension | ANDAANDA220016 | 1 | 2 |
| Amneal Ireland LimitedIreland | tablet, delayed release | ANDAANDA215067 | 1 | 1 |
| Lannett Company, LLCUnited States | tablet, delayed release | ANDAANDA217337 | 1 | 1 |
| ASCEND Therapeutics US, LLC | capsule, extended release | ANDAANDA214242 | 1 | 0 |
| Amring Pharmaceuticals Inc. | suppository | ANDAANDA208362 | 1 | 0 |
| AvKARE | tablet, delayed release | ANDAANDA213191 | 1 | 0 |
| AvPAK | capsule, extended release | ANDAANDA214242 | 1 | 0 |
| Chartwell RX, LLC. | tablet, delayed release | ANDAANDA217337 | 1 | 0 |
| Ingenus Pharmaceuticals, LLC | capsule, extended release | ANDAANDA218410 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet, delayed release | ANDAANDA091640 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | capsule, extended release | ANDAANDA207271 | 1 | 0 |
| NorthStar RxLLC | tablet, delayed release | ANDAANDA216334 | 1 | 0 |
| Northstar Rx, LLC, | suppository | ANDAANDA208953 | 1 | 0 |
| Nuvaila Limited | tablet, delayed release | ANDAANDA211858 | 1 | 0 |
| Oceanside Pharmaceuticals. | capsule, extended release | NDA AUTHORIZED GENERICNDA022301 | 1 | 0 |
| Salix Pharmaceuticals, Inc. | capsule, extended release | NDANDA022301 | 1 | 0 |
| Upsher-Smith Laboratories, Inc. | capsule, extended release | ANDAANDA217533 | 1 | 0 |
Bulk ingredient listings
- Pharmazell (India) Private LimitedIndia · 9 NDC
- CHEMI SpAItaly · 4 NDC
- DIVI'S LABORATORIES LIMITEDIndia · 2 NDC
- Erregierre SpAItaly · 2 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- CTX Lifesciences Pvt. Ltd.India · 1 NDC
- Cambrex Karlskoga ABSweden · 1 NDC
- Dasami Lab Private LimitedIndia · 1 NDC
- INFAR SASpain · 1 NDC
- IOL Chemicals and Pharmaceuticals Ltd.India · 1 NDC
- Ipca Laboratories LimitedIndia · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
- Maithri Drugs Private LimitedIndia · 1 NDC
- Matrix Pharmacorp Private LimitedIndia · 1 NDC
- Optimus Drugs Private LimitedIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Syntese A/SDenmark · 1 NDC
- Wanbury LimitedIndia · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Orange Book patents
4 unexpired patents list mesalamine as the active ingredient, expiring between Jul 2027 and May 2030. Application holders: ABBVIE INC, MYLAN SPECIALTY LP, SALIX PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes mesalamine?
- 36 companies list mesalamine as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Zydus Lifesciences Limited, Takeda Pharmaceuticals U.S.A., Inc., Pharma Packaging Solutions, LLC dba Tjoapack, LLC, Zydus Pharmaceuticals USA 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 APRISO?
- 31 companies list mesalamine under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies mesalamine active ingredient?
- 21 companies list mesalamine as a bulk ingredient, including Pharmazell (India) Private Limited, CHEMI SpA, DIVI'S LABORATORIES LIMITED, Erregierre SpA.