Simvastatin

Overview

Simvastatin is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL1064).

API suppliers (24)

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

• Lupin LimitedIndia1 active DMF GMP on record
• SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTDChina1 active DMF
• Zhejiang Jiangbei Pharmaceutical Co., Ltd.China1 active DMF
• Biocon LimitedIndia1 active DMF
• Teva Pharmaceutical Industries Ltd.Israel1 active DMF GMP on record
• JUBILANT BIOSYS LTDIndia1 active DMF
• ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO LTD1 active DMF
• ARTEMIS BIOTECH
• CONCORD BIOTECH LTDIndia GMP on record
• MYLAN LABORATORIES LTD GMP on record
• Hetero Labs LimitedIndia GMP on record
• STERLING BIOTECH LTDUnited States
• DR REDDYS LABORATORIES LTD GMP on record
• LEK PHARMACEUTICALS DD GMP on record
• SANDOZ INDUSTRIAL PRODUCTS SPA
• Sun Pharmaceutical Industries LimitedIndia GMP on record
• KREBS BIOCHEMICALS INDUSTRIES LTD
• Zhejiang Hisun Pharmaceutical Co., Ltd.China GMP on record
• APITORIA PHARMA PRIVATE LTDIndia GMP on record
• Glenmark PharmaceuticalsIndia GMP on record
• ZHEJIANG RUIBANG LABORATORIES INCChina
• Cadila Healthcare LimitedIndia
• ZHEJIANG APELOA PHARMACEUTICAL CO LTD
• SynthonNetherlands GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (60 approved US products), the latest listed US patent on Simvastatin expires 23 Feb 2030. Generic API sourcing typically opens up once these lapse.

Chemical identity

IUPAC name

[(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] 2,2-dimethylbutanoate

Canonical SMILES

CCC(C)(C)C(=O)O[C@H]1C[C@H](C=C2[C@H]1[C@H]([C@H](C=C2)C)CC[C@@H]3C[C@H](CC(=O)O3)O)C

InChIKey

RYMZZMVNJRMUDD-HGQWONQESA-N