Drug
Who makes varenicline tartrate?
22 companies list varenicline tartrate as a human prescription drug, including under the names CHANTIX. Forms: kit; 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 varenicline tartrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Dr. Reddys Laboratories Limited | kit; tablet, film coated | ANDAANDA215931 | 4 | 0 |
| Glenmark Pharmaceuticals Inc., USAIndia | kit; tablet, film coated | ANDAANDA214255 | 3 | 9 |
| Indoco Remedies LimitedIndia | kit; tablet, film coated | ANDAANDA219106 | 3 | 7 |
| Micro Labs LimitedIndia | kit; tablet, film coated | ANDAANDA218302 | 3 | 5 |
| Par Health USA, LLCIndia | kit; tablet, film coated | ANDAANDA201785 | 3 | 5 |
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA214557, ANDA219106 | 3 | 3 |
| Ajanta Pharma LimitedIndia | kit; tablet, film coated | ANDAANDA213019 | 3 | 2 |
| Camber Pharmaceuticals, Inc.United States | kit; tablet, film coated | ANDAANDA214571 | 3 | 1 |
| Florida Pharmaceutical Products LLCUnited States | kit; tablet, film coated | ANDAANDA219106 | 3 | 1 |
| Leading Pharma, LLCUnited States | kit; tablet, film coated | ANDAANDA217151 | 3 | 1 |
| ASCEND Therapeutics US, LLC | kit; tablet, film coated | ANDAANDA214557 | 3 | 0 |
| AvKARE | kit; tablet, film coated | ANDAANDA214557 | 3 | 0 |
| Kanchan Healthcare Inc | kit; tablet, film coated | ANDAANDA217151 | 3 | 0 |
| MAJOR Pharmaceuticals Inc. | kit; tablet, film coated | ANDAANDA214557 | 3 | 0 |
| NorthStar RxLLC | kit; tablet, film coated | ANDAANDA214571 | 3 | 0 |
| Pfizer Laboratories Div Pfizer Inc | kit; tablet, film coated | NDANDA021928 | 3 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, film coated | ANDAANDA201785, ANDA213019 | 2 | 5 |
| Marlex Pharmaceuticals, IncUnited States | tablet, film coated | ANDAANDA217283 | 2 | 1 |
| Proficient Rx LPUnited States | kit; tablet, film coated | NDANDA021928 | 2 | 1 |
| Lupin LimitedIndia | kit | ANDAANDA211862 | 1 | 14 |
| RemedyRepack, IncUnited States | tablet, film coated | ANDAANDA214571 | 1 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, film coated | NDANDA021928 | 1 | 0 |
Bulk ingredient listings
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Enaltec Labs Private LimitedIndia · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- Lee Pharma LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Matrix Pharmacorp Private LimitedIndia · 1 NDC
- Medichem SASpain · 1 NDC
- Par Active Technologies Private Limited · 1 NDC
- Piramal Healthcare (Canada) LimitedIndia · 1 NDC
- Teva API India Private Ltd.India · 1 NDC
- Viwit Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
12 unexpired patents list varenicline tartrate as the active ingredient, expiring between Oct 2035 and Oct 2035. Application holder: OYSTER POINT PHARMA INC.
Enquiry
Common questions
- Who makes varenicline tartrate?
- 22 companies list varenicline tartrate as a human prescription drug in the openFDA NDC Directory, led by Dr. Reddys Laboratories Limited, Glenmark Pharmaceuticals Inc., USA, Indoco Remedies Limited, Micro Labs Limited, Par Health USA, LLC. 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 CHANTIX?
- 19 companies list varenicline tartrate 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 varenicline tartrate active ingredient?
- 12 companies list varenicline tartrate as a bulk ingredient, including Dr. Reddy's Laboratories Limited, Enaltec Labs Private Limited, Hetero Drugs Limited, Jubilant Biosys Limited.