Drug
Who makes gemcitabine hydrochloride?
6 companies list gemcitabine hydrochloride as a human prescription drug. Forms: injection, powder, lyophilized, for solution; injection, solution. Routes: intravenous.
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 gemcitabine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Meitheal Pharmaceuticals, Inc. | injection, powder, lyophilized, for solution; injection, solution | ANDAANDA091365, ANDA212129 | 3 | 0 |
| Mylan Institutional Inc. | injection, solution | ANDAANDA205242 | 3 | 0 |
| GLAND PHARMA LIMITEDIndia | injection, powder, lyophilized, for solution | ANDAANDA204520 | 2 | 4 |
| Teyro Labs Private LimitedIndia | injection, powder, lyophilized, for solution | ANDAANDA078759 | 2 | 1 |
| Northstar Rx, LLC, | injection, powder, lyophilized, for solution | ANDAANDA091365 | 2 | 0 |
| Sagent Pharmaceuticals | injection, powder, lyophilized, for solution | ANDAANDA202485 | 2 | 0 |
Bulk ingredient listings
- Dr. Reddys Laboratories Limited · 1 NDC
- Emcure Pharmaceuticals LimitedIndia · 1 NDC
- Evonik Operations GmbHGermany · 1 NDC
- Farmhispania S.A.Spain · 1 NDC
- Hetero Labs LimitedIndia · 1 NDC
- Jiangsu Hansoh Pharmaceutical Group Co., Ltd.China · 1 NDC
- LAURUS LABS LIMITEDIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 1 NDC
- SciAnda (Changshu) Pharmaceuticals, Ltd.China · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Sicor de Mexico S.A. de C.V.Mexico · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
Orange Book patents
7 unexpired patents list gemcitabine hydrochloride as the active ingredient, expiring between Jun 2030 and Nov 2038. Application holders: JANSSEN BIOTECH INC, SUN PHARMACEUTICAL INDUSTRIES LTD.
Enquiry
Common questions
- Who makes gemcitabine hydrochloride?
- 6 companies list gemcitabine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Meitheal Pharmaceuticals, Inc., Mylan Institutional Inc., GLAND PHARMA LIMITED, Teyro Labs Private Limited, Northstar Rx, 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 gemcitabine hydrochloride?
- 6 companies list gemcitabine 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 gemcitabine hydrochloride active ingredient?
- 13 companies list gemcitabine hydrochloride as a bulk ingredient, including Dr. Reddys Laboratories Limited, Emcure Pharmaceuticals Limited, Evonik Operations GmbH, Farmhispania S.A..