Drug
Who makes colchicine?
31 companies list colchicine as a human prescription drug, including under the names Colcrys, Gloperba, MITIGARE. Forms: capsule; solution; tablet; 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 colchicine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | capsule; tablet; tablet, film coated | ANDA, NDA AUTHORIZED GENERICANDA208993, ANDA209876, ANDA211250 | 9 | 1 |
| International Medication Systems, Ltd.United States | capsule; tablet | ANDA, NDAANDA211250, ANDA211519, NDA204820 | 3 | 3 |
| Direct RxUnited States | tablet; tablet, film coated | ANDA, NDAANDA208993, ANDA209876, NDA022352 | 3 | 1 |
| Zydus Lifesciences LimitedIndia | tablet | ANDAANDA211519 | 2 | 12 |
| Granules Pharmaceuticals Inc.India | capsule; tablet, film coated | ANDAANDA210425, ANDA210757 | 2 | 8 |
| Par Health USA, LLCIndia | capsule; tablet, film coated | ANDAANDA203976, ANDA208678 | 2 | 5 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule; tablet, film coated | ANDA, NDAANDA203976, NDA204820 | 2 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | capsule | NDANDA204820 | 2 | 4 |
| Camber Pharmaceuticals, Inc.United States | capsule; tablet, film coated | ANDAANDA208993, ANDA217620 | 2 | 1 |
| Coupler LLCUnited States | capsule | ANDA, NDAANDA217620, NDA204820 | 2 | 1 |
| Proficient Rx LPUnited States | tablet; tablet, film coated | ANDA, NDAANDA209876, NDA022352 | 2 | 1 |
| RemedyRepack, IncUnited States | tablet; tablet, film coated | ANDAANDA209876, ANDA210425 | 2 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet | ANDAANDA211519 | 2 | 1 |
| MAJOR Pharmaceuticals Inc. | capsule; tablet, film coated | ANDA, NDAANDA210425, NDA204820 | 2 | 0 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA215444 | 1 | 6 |
| Macleods Pharmaceuticals LimitedIndia | tablet | ANDAANDA210633 | 1 | 5 |
| Micro Labs LimitedIndia | capsule | ANDAANDA212880 | 1 | 5 |
| Strides Pharma Science LimitedIndia | tablet, film coated | ANDAANDA209173 | 1 | 5 |
| Amneal Ireland LimitedIreland | tablet | ANDAANDA204711 | 1 | 1 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA210425 | 1 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet | ANDAANDA211250 | 1 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA208993 | 1 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet | ANDAANDA211250 | 1 | 1 |
| ASCEND Therapeutics US, LLC | tablet | ANDAANDA211250 | 1 | 0 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, film coated | ANDAANDA210425 | 1 | 0 |
| AvPAK | tablet | ANDAANDA204711 | 1 | 0 |
| Chartwell RX, LLC. | tablet, film coated | ANDAANDA209173 | 1 | 0 |
| Dr. Reddys Laboratories Limited | tablet | ANDAANDA209876 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet, film coated | ANDAANDA209470 | 1 | 0 |
| Northstar Rx, LLC, | tablet | ANDAANDA211519 | 1 | 0 |
| Scilex Pharmaceuticals Inc. | solution | NDANDA210942 | 1 | 0 |
Bulk ingredient listings
- ALKALOIDS BIOACTIVES PRIVATE LIMITEDIndia · 1 NDC
- Alchem International Private LtdUnited States · 1 NDC
- HARMAN FINOCHEM LIMITEDIndia · 1 NDC
- Honour Lab LimitedIndia · 1 NDC
- Indena SpAItaly · 1 NDC
- Par Active Technologies Private Limited · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- SOLARA ACTIVE PHARMA SCIENCES LIMITEDIndia · 1 NDC
- Supriya Lifescience LimitedIndia · 1 NDC
Orange Book patents
41 unexpired patents list colchicine as the active ingredient, expiring between Oct 2028 and Dec 2037. Application holders: AGEPHA PHARMA FZ LLC, HIKMA INTERNATIONAL PHARMACEUTICALS LLC, SCILEX PHARMACEUTICALS INC, TAKEDA PHARMACEUTICALS USA INC.
Enquiry
Common questions
- Who makes colchicine?
- 31 companies list colchicine as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, International Medication Systems, Ltd., Direct Rx, Zydus Lifesciences Limited, Granules 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 Colcrys?
- 29 companies list colchicine under an abbreviated new drug application (ANDA), the application type used for generics, and 8 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies colchicine active ingredient?
- 9 companies list colchicine as a bulk ingredient, including ALKALOIDS BIOACTIVES PRIVATE LIMITED, Alchem International Private Ltd, HARMAN FINOCHEM LIMITED, Honour Lab Limited.