TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
01 2TAPI Technology & API Services
02 1Artemis Biotech
03 1Aurobindo Pharma Limited
04 2Biocon
05 1Glenmark Pharmaceuticals
06 2HEC Pharm
07 2HENAN TOPFOND PHARMACEUTICAL Co,. Ltd
08 2Hetero Drugs
09 1Jubilant Generics
10 1Krebs Biochemicals & Industries Ltd
11 1Lek Pharmaceuticals
12 1Lupin Ltd
13 1RANBAXY LABORATORIES LIMITED
14 1SYNTHON Chemicals GmbH & Co. KG
15 1Sandoz B2B
16 2Southwest Synthetic Pharmaceutical
17 1Sterling Biotech
18 1Viatris
19 1Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd
20 2Zhejiang Hisun Pharmaceutical
21 5Zhejiang Jiangbei Pharmaceutical
22 1Zhejiang Ruibang Laboratories
23 3Zydus Lifesciences
01 10SIMVASTATIN
02 1SIMVASTATIN (DRUG SUBSTANCE)
03 1SIMVASTATIN ( LOVASTATIN ROUTE)
04 1SIMVASTATIN (AMMONIUM SALT ROUTE)
05 1SIMVASTATIN (BHA ADDED) USP
06 1SIMVASTATIN (ETHANOL PROCESS)
07 1SIMVASTATIN (WITH 0.01% BHA)
08 2SIMVASTATIN AMMONIUM SALT
09 1SIMVASTATIN AMMONIUM SALT (ALTERNATIVE PROCESS)
10 1SIMVASTATIN NON-STERILE BULK DRUG SUBSTANCE
11 1SIMVASTATIN NON-STERILE DRUG SUBSTANCE, BULK FORM
12 12SIMVASTATIN USP
13 1SIMVASTATIN USP BULK
14 1SIMVASTATIN, NON-STERILE BULK FORM
15 1SIMVASTATIN, USP (PROCESS II)
01 15China
02 1Germany
03 15India
04 2Israel
05 1Slovenia
06 1Switzerland
07 1U.S.A
01 13Active
02 23Inactive
01 9Complete
02 27Blank
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14599
Submission : 1999-11-29
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-13
Pay. Date : 2012-11-13
DMF Number : 25024
Submission : 2011-06-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-15
Pay. Date : 2013-03-01
DMF Number : 18449
Submission : 2005-06-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19545
Submission : 2006-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-07-05
DMF Number : 27231
Submission : 2013-06-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18755
Submission : 2005-09-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-17
Pay. Date : 2017-02-28
DMF Number : 17934
Submission : 2004-12-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-18
Pay. Date : 2013-09-23
DMF Number : 23425
Submission : 2009-12-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-29
Pay. Date : 2012-11-15
DMF Number : 16305
Submission : 2002-12-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-20
Pay. Date : 2016-09-26
DMF Number : 26971
Submission : 2013-03-04
Status : Active
Type : II
A Simvastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Simvastatin, including repackagers and relabelers. The FDA regulates Simvastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Simvastatin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Simvastatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Simvastatin supplier is an individual or a company that provides Simvastatin active pharmaceutical ingredient (API) or Simvastatin finished formulations upon request. The Simvastatin suppliers may include Simvastatin API manufacturers, exporters, distributors and traders.
click here to find a list of Simvastatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Simvastatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Simvastatin active pharmaceutical ingredient (API) in detail. Different forms of Simvastatin DMFs exist exist since differing nations have different regulations, such as Simvastatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Simvastatin DMF submitted to regulatory agencies in the US is known as a USDMF. Simvastatin USDMF includes data on Simvastatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Simvastatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Simvastatin suppliers with USDMF on PharmaCompass.
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