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

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01 Dr. Reddy's Laboratories (1)

02 Biophore India Pharmaceuticals Pvt Ltd (1)

03 Metrochem API Private Limited (1)

04 Alkem Laboratories (1)

05 Ami Lifesciences Private Limited (1)

06 Aurisco Pharmaceutical (1)

07 Aurobindo Pharma Limited (1)

08 Everest Organics (1)

09 HONOUR LAB LTD (1)

10 Lee Pharma (1)

11 Micro Labs Limited (1)

12 Optimus Pharma (1)

13 Blank (1)

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01 BEMPEDOIC ACID (13)

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01 China (1)

02 India (11)

03 Blank (1)

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01 Active (13)

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01 Complete (9)

02 Blank (4)

URL Supplier Web Content
37511
Active
2022-10-03
N/A
II
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URL Supplier Web Content
36942
Active
2022-04-23
Complete
2022-06-21
2022-03-21
II
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URL Supplier Web Content
37973
Active
2023-01-30
N/A
II
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URL Supplier Web Content
36010
Active
2021-06-28
N/A
II
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URL Supplier Web Content
37788
Active
2023-03-20
Complete
2023-05-09
2023-03-31
II
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URL Supplier Web Content
35956
Active
2021-06-11
Complete
2021-08-24
2021-06-11
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APICHEM LABORATORIES PRIVATE LTD

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URL Supplier Web Content
36773
Active
2022-02-28
Complete
2023-09-18
2023-08-18
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Looking for 738606-46-7 / Bempedoic Acid API manufacturers, exporters & distributors?

Bempedoic Acid manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Bempedoic Acid 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 Bempedoic Acid manufacturer or Bempedoic Acid supplier for your needs.

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

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

API | Excipient name

Bempedoic Acid

Synonyms

Etc-1002, 738606-46-7, 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid, Nexletol, Esp-55016, Nilemdo

Cas Number

738606-46-7

Unique Ingredient Identifier (UNII)

1EJ6Z6Q368

About Bempedoic Acid

High levels of LDL cholesterol (LDL-C) are a major risk factor for cardiovascular events. Caused by genetic mutations or lifestyle factors, hypercholesterolemia can significantly reduce quality of life and increase the risk of mortality from cardiovascular disease. About 1 in 4 patients, or 15 million Americans with elevated LDL-C, are insufficiently managed with maximally tolerated statin therapy alone, requiring additional treatment for hypercholesterolemia. Bempedoic acid is first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor used once a day for reducing LDL cholesterol levels in statin-refractory patients. It was developed by Esperion Therapeutics Inc. and approved by the FDA on February 21, 2020. A combination product of bempedoic acid and [ezetimibe] was approved on February 26, 2020 for increased control of LDL cholesterol levels in patients experiencing refractory elevations despite previous statin treatment.

Bempedoic Acid Manufacturers

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

Bempedoic Acid Suppliers

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

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

Bempedoic Acid USDMF

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

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

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

Bempedoic Acid Manufacturers | Traders | Suppliers

Bempedoic Acid Manufacturers, Traders, Suppliers 1
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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