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List of Drug Master Files (DMF) of 0462Z4S4OZ Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Biophore India Pharmaceuticals Pvt Ltd (1)

02 Moehs Iberica (1)

03 Alembic Pharmaceuticals Limited (1)

04 BrightGene Bio-Medical Technology Co.,Ltd (1)

05 Changzhou Pharmaceutical Factory (1)

06 Hetero Drugs (1)

07 Industriale Chimica s.r.l. (1)

08 Kaifeng Pharmaceutical Group Co., Ltd (1)

09 MSN Laboratories (1)

10 Optimus Pharma (1)

11 Solara Active Pharma Sciences (1)

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01 OBETICHOLIC ACID (11)

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01 China (3)

02 India (6)

03 Italy (1)

04 Spain (1)

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01 Active (11)

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01 Complete (6)

02 Blank (5)

URL Supplier Web Content
34333
Active
2019-12-11
N/A
II
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URL Supplier Web Content
36292
Active
2021-09-29
Complete
2022-01-31
2021-09-16
II
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URL Supplier Web Content
37355
Active
2022-08-15
Complete
2023-02-15
2023-01-17
II
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URL Supplier Web Content
34282
Active
2019-11-13
Complete
2020-02-13
2019-11-13
II
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URL Supplier Web Content
33776
Active
2019-06-05
N/A
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URL Supplier Web Content
33610
Active
2019-02-28
Complete
2019-08-01
2019-07-08
II
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URL Supplier Web Content
33960
Active
2019-11-07
Complete
2019-12-26
2019-11-06
II
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URL Supplier Web Content
34561
Active
2020-02-14
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Looking for 459789-99-2 / Obeticholic Acid API manufacturers, exporters & distributors?

Obeticholic Acid manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Obeticholic Acid

Synonyms

459789-99-2, 6-ecdca, Int-747, 6-ethylchenodeoxycholic acid, Ocaliva, Obetichloic acid

Cas Number

459789-99-2

Unique Ingredient Identifier (UNII)

0462Z4S4OZ

About Obeticholic Acid

Obeticholic Acid is an orally bioavailable semi-synthetic bile acid derivative and an agonist of the nuclear bile acid receptor farnesoid X receptor (FXR) that may be used to lower hepatic exposure to bile acids. Upon oral administration, obeticholic acid targets and binds to FXR expressed in the liver and intestine, activating FXR-mediated bile acid, inflammatory, fibrotic, and metabolic pathways. This suppresses the production of bile acid in the hepatocytes and increases bile acid transport out of the hepatocytes, thereby reducing hepatic exposure to bile acids. FXR plays an important role in bile acid homeostasis and is involved in hepatic and intestinal inflammation and liver fibrosis.

0462Z4S4OZ Manufacturers

A 0462Z4S4OZ manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 0462Z4S4OZ, including repackagers and relabelers. The FDA regulates 0462Z4S4OZ manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 0462Z4S4OZ 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 0462Z4S4OZ manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

0462Z4S4OZ Suppliers

A 0462Z4S4OZ supplier is an individual or a company that provides 0462Z4S4OZ active pharmaceutical ingredient (API) or 0462Z4S4OZ finished formulations upon request. The 0462Z4S4OZ suppliers may include 0462Z4S4OZ API manufacturers, exporters, distributors and traders.

click here to find a list of 0462Z4S4OZ suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

0462Z4S4OZ USDMF

A 0462Z4S4OZ DMF (Drug Master File) is a document detailing the whole manufacturing process of 0462Z4S4OZ active pharmaceutical ingredient (API) in detail. Different forms of 0462Z4S4OZ DMFs exist exist since differing nations have different regulations, such as 0462Z4S4OZ USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 0462Z4S4OZ DMF submitted to regulatory agencies in the US is known as a USDMF. 0462Z4S4OZ USDMF includes data on 0462Z4S4OZ's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 0462Z4S4OZ USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 0462Z4S4OZ suppliers with USDMF on PharmaCompass.

0462Z4S4OZ Manufacturers | Traders | Suppliers

0462Z4S4OZ 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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