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List of all Manufacturers, Suppliers & Exporters of Obeticholic Acid API listed on PharmaCompass with details of regulatory filings

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01 Kimia Biosciences (1)

02 Biophore India Pharmaceuticals Pvt Ltd (1)

03 Extrovis AG (1)

04 LGM Pharma (1)

05 Moehs Iberica (1)

06 Alembic Pharmaceuticals Limited (2)

07 Ami Lifesciences Private Limited (1)

08 Aurisco Pharmaceutical (1)

09 Bacto Chem (1)

10 Beijing Mesochem Technology (1)

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

12 CHEMO (1)

13 Changzhou Pharmaceutical Factory (1)

14 Chromo Laboratories (1)

15 Guangzhou Tosun Pharmaceutical (1)

16 Hetero Drugs (1)

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

18 Kaifeng Pharmaceutical Group Co., Ltd (1)

19 MSN Laboratories (1)

20 Mankind Pharma (1)

21 Omgene Life Sciences (1)

22 Optimus Pharma (1)

23 Sichuan Renan Pharmaceutical (1)

24 Sichuan Xieli Pharmaceutical (1)

25 Solara Active Pharma Sciences (1)

26 Viruj Pharmaceuticals Pvt Ltd (1)

27 Waterstone Pharmaceuticals Inc. (1)

28 Yonsung Fine Chemicals (1)

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01 China (9)

02 India (14)

03 Italy (1)

04 South Korea (1)

05 Spain (2)

06 Switzerland (1)

07 U.S.A (1)

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01 Active (11)

02 Blank (18)

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01 Blank (29)

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01 Blank (29)

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01 WC-0054A4 (1)

02 WC-0082 (1)

03 WC-0082A11 (1)

04 WC-0383A8 (1)

05 WC-0474A3 (1)

06 WC-0511 (1)

07 Blank (23)

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
Indian CDSCO WC-0474A3
Status
 
Expired
2023-06-17
Filing Details
Obeticholic Acid IH
Issue/Submission Date
2021-04-09
Kimia Biosciences

Iran Expo

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USDMF

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Application Number
34413
Indian CDSCO WC-0511
Status
Active
Fees Paid
Reviewed
 
Valid
2024-10-21
Filing Details
OBETICHOLIC ACID
Obeticholic Acid IH
Issue/Submission Date
2019-12-27
2021-10-22
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USDMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Extrovis Company Banner

Iran Expo

Not Confirmed

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USDMF

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CEP/COS

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Application Number
38221
Status
Active
Fees Paid
N/A
 
Filing Details
OBETICHOLIC ACID
Issue/Submission Date
2023-03-27
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USDMF

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Application Number
36292
Status
Active
Fees Paid
Reviewed
 
Filing Details
OBETICHOLIC ACID
Issue/Submission Date
2021-09-29
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USDMF

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Application Number
34561
Status
Active
Fees Paid
N/A
 
Filing Details
OBETICHOLIC ACID
Issue/Submission Date
2020-02-14
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USDMF

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Application Number
38348
Status
Active
Fees Unpaid
N/A
 
Filing Details
OBETICHOLIC ACID
Issue/Submission Date
2023-05-04
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USDMF

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Written Confirmation

Caution WC

Application Number
33610
Indian CDSCO WC-0383A8
Status
Active
Fees Paid
Reviewed
 
Expired
2022-08-08
Filing Details
OBETICHOLIC ACID
Obeticholic Acid IH
Issue/Submission Date
2019-02-28
2021-02-12
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USDMF

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Application Number
33960
Status
Active
Fees Paid
Reviewed
 
Filing Details
OBETICHOLIC ACID
Issue/Submission Date
2019-11-07
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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.

Obeticholic Acid Manufacturers

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

Obeticholic Acid Suppliers

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

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