Drug
Who makes palbociclib?
2 companies list palbociclib as a human prescription drug, including under the names Ibrance. Forms: capsule; 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 palbociclib
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc | capsule; tablet, film coated | NDANDA207103, NDA212436 | 6 | 0 |
| U.S. Pharmaceuticals | tablet, film coated | NDANDA212436 | 3 | 0 |
Bulk ingredient listings
- Zhejiang Ausun Pharmaceutical Co., Ltd.China · 2 NDC
- AARTI PHARMALABS LIMITEDIndia · 1 NDC
- Chunghwa Chemical Synthesis & Biotech Co., Ltd. · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Hetero Labs LimitedIndia · 1 NDC
- Lianyungang Runzhong Pharmaceutical Co., Ltd.,China · 1 NDC
- MAEDA INCUnited States · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Pfizer IncUnited States · 1 NDC
- Pfizer Ireland Pharmaceuticals Unlimited Company · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Shandong Anhong Pharmaceutical Co., Ltd.China · 1 NDC
- Sionc Pharmaceuticals Private LimitedIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Viyash Life Sciences Private Limited · 1 NDC
Orange Book patents
6 unexpired patents list palbociclib as the active ingredient, expiring between Mar 2027 and Feb 2037. Application holder: PFIZER INC.
Enquiry
Common questions
- Who makes palbociclib?
- 2 companies list palbociclib as a human prescription drug in the openFDA NDC Directory, led by Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Who supplies palbociclib active ingredient?
- 15 companies list palbociclib as a bulk ingredient, including Zhejiang Ausun Pharmaceutical Co., Ltd., AARTI PHARMALABS LIMITED, Chunghwa Chemical Synthesis & Biotech Co., Ltd., Dr. Reddy's Laboratories Limited.