Zoledronic Acid
Overview
Zoledronic acid is a bisphosphonate drug used to prevent skeletal fractures in patients with cancers such as multiple myeloma and prostate cancer, as well as for treating osteoporosis. It works by inhibiting the activity of osteoclasts, cells that break down bone tissue.
API suppliers (22)
Suppliers of Zoledronic Acid evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
Country recorded for 17 of 22 suppliers.
10 of 22 hold a GMP certificate on record in the EU or UK registers
- Shandong New Time Pharmaceutical Co Ltd2 active DMF GMP on record
- Natco PharmaIndia1 active DMF GMP on record
- TAPI NL BVNetherlands1 active DMF
- JUBILANT BIOSYS LTDIndia1 active DMF
- Sun Pharmaceutical Industries LimitedIndia1 active DMF GMP on record
- Wockhardt UsaUnited Kingdom1 active DMF
- DR REDDYS LABORATORIES LTD1 active DMF GMP on record
- Hetero Labs LimitedIndia1 active DMF GMP on record
- SHILPA PHARMA LIFESCIENCES LTDIndia1 active DMF
- MAPRIMED SAArgentina1 active DMF GMP on record
- YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD1 active DMF
- TRIFARMA SPAItaly1 active DMF GMP on record
- SCINOPHARM TAIWAN LTDTaiwan1 active DMF
- Hikma Pharmaceuticals Usa IncUnited Kingdom1 active DMF
- GADOR SAArgentina1 active DMF
- Emcure Pharmaceuticals LimitedIndia1 active DMF GMP on record
- ZAKLADY FARMACEUTYCZNE POLPHARMA SA1 active DMF
- MYLAN LABORATORIES LTD GMP on record
- Cipla USA, Inc.USA
- Ipca Laboratories LimitedIndia GMP on record
- PISGAH LABS INCUnited States
- LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTDChina
Patent & exclusivity (US)
Per the FDA Orange Book (26 approved US products), the latest listed US patent on Zoledronic Acid expires 5 Aug 2028. Generic API sourcing typically opens up once these lapse.
Chemical identity
- IUPAC name
- thiolane 1,1-dioxide
- Canonical SMILES
- C1CCS(=O)(=O)C1
- InChIKey
- HXJUTPCZVOIRIF-UHFFFAOYSA-N
Therapeutic areas
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