Drug
Who makes gefitinib?
5 companies list gefitinib as a human prescription drug, including under the names IRESSA. Forms: tablet, coated; 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 gefitinib
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| AstraZeneca PLCUnited States | tablet, coated | NDANDA206995 | 1 | 15 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet, film coated | ANDAANDA208913 | 1 | 6 |
| NATCO PHARMA LIMITEDIndia | tablet, film coated | ANDAANDA212827 | 1 | 5 |
| Qilu Pharmaceutical Co., Ltd.China | tablet, coated | ANDAANDA211591 | 1 | 5 |
| Ingenus Pharmaceuticals, LLC | tablet, coated | ANDAANDA211591 | 1 | 0 |
Bulk ingredient listings
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- Hetero Labs LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- NATCO PHARMA LIMITEDIndia · 1 NDC
- SciAnda (Changshu) Pharmaceuticals, Ltd.China · 1 NDC
- Wisdom Pharmaceutical Co., Ltd.China · 1 NDC
- Zhejiang Jiuzhou Pharmaceutical Co., Ltd.China · 1 NDC
Enquiry
Common questions
- Who makes gefitinib?
- 5 companies list gefitinib as a human prescription drug in the openFDA NDC Directory, led by AstraZeneca PLC, Teva Pharmaceutical Industries Ltd., NATCO PHARMA LIMITED, Qilu Pharmaceutical Co., Ltd., Ingenus Pharmaceuticals, 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 IRESSA?
- 4 companies list gefitinib under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies gefitinib active ingredient?
- 7 companies list gefitinib as a bulk ingredient, including CIPLA PHARMACEUTICALS LIMITED, Hetero Labs Limited, MSN Laboratories Private Limited,, NATCO PHARMA LIMITED.