Drug
Who makes valganciclovir hydrochloride?
12 companies list valganciclovir hydrochloride as a human prescription drug, including under the names Valcyte. Forms: for solution; powder, for solution; tablet; 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 valganciclovir hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Strides Pharma Science LimitedIndia | tablet, film coated | ANDAANDA200790 | 2 | 5 |
| AvKARE | powder, for solution; tablet, film coated | ANDAANDA200790, ANDA205220 | 2 | 0 |
| Dr. Reddy's Laboratories LimitedIndia | tablet | ANDAANDA206876 | 1 | 15 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA204750 | 1 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | powder, for solution | ANDAANDA211475 | 1 | 5 |
| Ajanta Pharma LimitedIndia | powder, for solution | ANDAANDA212890 | 1 | 2 |
| Actavis LLCUnited States | powder, for solution | ANDAANDA205220 | 1 | 1 |
| Camber Pharmaceuticals, Inc.United States | powder, for solution | ANDAANDA211475 | 1 | 1 |
| H2-Pharma, LLC | powder, for solution | NDANDA022257 | 1 | 0 |
| NorthStar RxLLC | powder, for solution | ANDAANDA211475 | 1 | 0 |
| Northstar Rx, LLC, | tablet | ANDAANDA204750 | 1 | 0 |
| Novadoz Pharmaceuticals LLC | for solution | ANDAANDA210169 | 1 | 0 |
Bulk ingredient listings
- Dr. Reddy's Laboratories LimitedIndia · 2 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Corden Pharma Colorado, Inc.United States · 1 NDC
- DISHMAN CARBOGEN AMCIS LIMITEDIndia · 1 NDC
- Dasami Lab Private LimitedIndia · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- Maithri Laboratories Private LimitedIndia · 1 NDC
- Matrix Pharmacorp Private LimitedIndia · 1 NDC
- Olon USA LLCItaly · 1 NDC
- Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd.China · 1 NDC
- Zhejiang Charioteer Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
2 unexpired patents list valganciclovir hydrochloride as the active ingredient, expiring between Dec 2027 and Dec 2027. Application holder: CHEPLAPHARM ARZNEIMITTEL GMBH.
Enquiry
Common questions
- Who makes valganciclovir hydrochloride?
- 12 companies list valganciclovir hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Strides Pharma Science Limited, AvKARE, Dr. Reddy's Laboratories Limited, Aurobindo Pharma Limited, Pharma Packaging Solutions, LLC dba Tjoapack, 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 Valcyte?
- 11 companies list valganciclovir hydrochloride 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 valganciclovir hydrochloride active ingredient?
- 11 companies list valganciclovir hydrochloride as a bulk ingredient, including Dr. Reddy's Laboratories Limited, Aurobindo Pharma Limited, Corden Pharma Colorado, Inc., DISHMAN CARBOGEN AMCIS LIMITED.