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.

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

EU CEP holders (8)

Companies holding a valid EU Certificate of Suitability (CEP) for Simvastatin, from the EDQM certification database. A CEP holder is a documented EU-market source of the substance — not necessarily the manufacturer — and these are not yet profiled in our directory.

Patent & exclusivity (US)

Per the FDA Orange Book (55 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