Drug
Who makes erlotinib hydrochloride?
3 companies list erlotinib hydrochloride as a human prescription drug. Forms: 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 erlotinib hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alembic Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA214719 | 6 | 7 |
| Armas Pharmaceuticals, Inc. | tablet, film coated | ANDAANDA211960 | 3 | 0 |
| Novadoz Pharmaceuticals LLC | tablet, film coated | ANDAANDA214366 | 3 | 0 |
Bulk ingredient listings
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 2 NDC
- Sicor de Mexico S.A. de C.V.Mexico · 2 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Sichuan Xieli Pharmaceutical Co LtdChina · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Valary Lab Private LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes erlotinib hydrochloride?
- 3 companies list erlotinib hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, Armas Pharmaceuticals, Inc., Novadoz 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 erlotinib hydrochloride?
- 3 companies list erlotinib hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies erlotinib hydrochloride active ingredient?
- 8 companies list erlotinib hydrochloride as a bulk ingredient, including SHILPA PHARMA LIFESCIENCES LIMITED, Sicor de Mexico S.A. de C.V., CIPLA PHARMACEUTICALS LIMITED, FIS FABBRICA ITALIANA SINTETICI SPA.