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List of Drug Master Files (DMF) of Prestwick3_000865 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Artemis Biotech (1)

02 Aurobindo Pharma Limited (1)

03 Biocon (2)

04 Glenmark Pharmaceuticals (1)

05 HEC Pharm (2)

06 HENAN TOPFOND PHARMACEUTICAL Co,. Ltd (4)

07 Hetero Drugs (2)

08 Jubilant Generics (1)

09 Krebs Biochemicals & Industries Ltd (2)

10 Lek Pharmaceuticals (1)

11 Lupin Ltd (1)

12 RANBAXY LABORATORIES LIMITED (1)

13 SYNTHON Chemicals GmbH & Co. KG (1)

14 Sandoz B2B (1)

15 Southwest Synthetic Pharmaceutical Corp. (2)

16 Sterling Biotech (2)

17 Teva API (2)

18 Viatris (1)

19 Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd (1)

20 Zhejiang Hisun Pharmaceutical (2)

21 Zhejiang Jiangbei Pharmaceutical Co., Ltd. (4)

22 Zhejiang Ruibang Laboratories (1)

23 Zydus Lifesciences (3)

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01 SIMVASTATIN (9)

02 SIMVASTATIN (DRUG SUBSTANCE) (1)

03 SIMVASTATIN ( LOVASTATIN ROUTE) (1)

04 SIMVASTATIN (AMMONIUM SALT ROUTE) (1)

05 SIMVASTATIN (BHA ADDED) USP (1)

06 SIMVASTATIN (ETHANOL PROCESS) (1)

07 SIMVASTATIN (WITH 0.01% BHA) (1)

08 SIMVASTATIN AMMONIUM SALT (2)

09 SIMVASTATIN AMMONIUM SALT (ALTERNATIVE PROCESS) (1)

10 SIMVASTATIN AMMONIUM SALT (DRUG SUBSTANCE INTERMEDIATE) (1)

11 SIMVASTATIN AMMONIUM SALT (INTERMEDIATE) (2)

12 SIMVASTATIN AMMONIUM SALT(DRUG SUBSTANCE INTERMEDIATE) (1)

13 SIMVASTATIN NON-STERILE BULK DRUG SUBSTANCE (1)

14 SIMVASTATIN NON-STERILE DRUG SUBSTANCE, BULK FORM (1)

15 SIMVASTATIN USP (12)

16 SIMVASTATIN USP BULK (1)

17 SIMVASTATIN, NON-STERILE BULK FORM (1)

18 SIMVASTATIN, USP (PROCESS II) (1)

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01 China (16)

02 Germany (1)

03 India (17)

04 Israel (2)

05 Slovenia (1)

06 Switzerland (1)

07 U.S.A (1)

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01 Active (15)

02 Inactive (24)

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01 Complete (9)

02 Blank (30)

URL Supplier Web Content
17829
Active
2004-11-08
N/A
II
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URL Supplier Web Content
18449
Active
2005-06-23
Complete
2013-03-15
2013-03-01
II
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19545
Active
2006-04-20
N/A
II
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18755
Active
2005-09-13
N/A
II
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URL Supplier Web Content
17934
Active
2004-12-27
Complete
2017-03-17
2017-02-28
II
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URL Supplier Web Content
23425
Active
2009-12-29
Complete
2014-08-18
2013-09-23
II
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URL Supplier Web Content
25024
Active
2011-06-08
Complete
2014-01-13
2012-11-13
II
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14599
Active
1999-11-29
N/A
II
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URL Supplier Web Content
16305
Active
2002-12-11
Complete
2013-08-29
2012-11-15
II
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26971
Active
2013-03-04
Complete
2017-03-20
2016-09-26
II
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Looking for 79902-63-9 / Simvastatin API manufacturers, exporters & distributors?

Simvastatin manufacturers, exporters & distributors 1

35

PharmaCompass offers a list of Simvastatin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Simvastatin manufacturer or Simvastatin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Simvastatin manufacturer or Simvastatin supplier.

PharmaCompass also assists you with knowing the Simvastatin API Price utilized in the formulation of products. Simvastatin API Price is not always fixed or binding as the Simvastatin Price is obtained through a variety of data sources. The Simvastatin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Simvastatin

Synonyms

79902-63-9, Zocor, Synvinolin, Mk-733, Sinvacor, Denan

Cas Number

79902-63-9

Unique Ingredient Identifier (UNII)

AGG2FN16EV

About Simvastatin

A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.

Prestwick3_000865 Manufacturers

A Prestwick3_000865 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prestwick3_000865, including repackagers and relabelers. The FDA regulates Prestwick3_000865 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prestwick3_000865 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 Prestwick3_000865 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Prestwick3_000865 Suppliers

A Prestwick3_000865 supplier is an individual or a company that provides Prestwick3_000865 active pharmaceutical ingredient (API) or Prestwick3_000865 finished formulations upon request. The Prestwick3_000865 suppliers may include Prestwick3_000865 API manufacturers, exporters, distributors and traders.

click here to find a list of Prestwick3_000865 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Prestwick3_000865 USDMF

A Prestwick3_000865 DMF (Drug Master File) is a document detailing the whole manufacturing process of Prestwick3_000865 active pharmaceutical ingredient (API) in detail. Different forms of Prestwick3_000865 DMFs exist exist since differing nations have different regulations, such as Prestwick3_000865 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Prestwick3_000865 DMF submitted to regulatory agencies in the US is known as a USDMF. Prestwick3_000865 USDMF includes data on Prestwick3_000865's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prestwick3_000865 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Prestwick3_000865 suppliers with USDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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