Valganciclovir

Overview

Valganciclovir is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL1201314).

API suppliers (12)

Suppliers of Valganciclovir evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• OLON SPAItaly4 active DMF GMP on record
• APITORIA PHARMA PRIVATE LTDIndia2 active DMF GMP on record
• MATRIX PHARMACORP PRIVATE LTDIndia2 active DMF
• DR REDDYS LABORATORIES LTD2 active DMF GMP on record
• Ajanta Pharma LimitedIndia1 active DMF
• Maithri Laboratories Private LimitedIndia1 active DMF GMP on record
• AURORE LIFE SCIENCES PRIVATE LTD1 active DMF GMP on record
• Hetero Drugs LimitedIndia1 active DMF GMP on record
• Cipla USA, Inc.USA1 active DMF
• Zhejiang Charioteer Pharmaceutical Co., Ltd.China GMP on record
• Apotex Pharmachem India Pvt. Ltd.India
• Sun Pharmaceutical Industries LimitedIndia GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (18 approved US products), the latest listed US patent on Valganciclovir expires 11 Dec 2027. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

[2-[(2-amino-6-oxo-3H-purin-9-yl)methoxy]-3-hydroxypropyl] (2S)-2-amino-3-methylbutanoate

Canonical SMILES

CC(C)[C@@H](C(=O)OCC(CO)OCN1C=NC2=C1NC(=NC2=O)N)N

InChIKey

WPVFJKSGQUFQAP-GKAPJAKFSA-N