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Sichuan Elixir Pharmaceuticals Ursodeoxycholic Acid Sichuan Elixir Pharmaceuticals Ursodeoxycholic Acid

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List of Drug Master Files (KDMF) for Ursodiol Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Farmabios SPA (1)

02 ICE SPA@Raichem Medicare Pvt. Ltd (1)

03 Daewoong Bio Co., Ltd.@Zhejiang Warrant Pharmaceutical Co., Ltd@Hunan Jiudian Hongyang Pharmaceutical.Co.,Ltd (1)

04 Korea Biochem Pharmaceutical Co., Ltd. @Zhongshan Belling Biotechnology Co., Ltd (1)

05 Shilpa Pharma Lifesciences Limited (unit-2) (1)

06 Suzhou Tianlu Bio-Pharmaceuticals Co.,Ltd. (2)

07 Suzhou Tianlu Bio-pharmaceutical Co., Ltd (6)

08 Zhongshan Belling Biotechnology Co.,Ltd. (1)

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01 Ace Biopharm Co., Ltd. (1)

02 Daesin Pharmaceutical Co., Ltd. (1)

03 Daewoong Bio Co., Ltd. (1)

04 Eltech Pharmachem Co., Ltd. (1)

05 Fine Farm Co., Ltd. (1)

06 JSP Co., Ltd. (1)

07 Kookjeon Pharmaceutical Co., Ltd. (1)

08 Korea Biochem Pharmaceutical Co., Ltd. (1)

09 Otran Farm Korea Co., Ltd. (1)

10 Pampia Co., Ltd. (1)

11 SG Biochem Co., Ltd. (1)

12 Samo Pharmaceutical Co., Ltd. (1)

13 Sanil Pharmaceutical Co., Ltd. (1)

14 Sechang International Co., Ltd. (1)

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01 Ursodeoxycholic acid (14)

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01 China (9)

02 Germany (1)

03 India (1)

04 Italy (1)

05 South Korea (2)

Eltech Pharmachem Co., Ltd.
2020-08-13
20200813-211-J-501
Farmabios SPA
Italy
Via Pavia 1-27027, GROPEL...
Axplora CB

Iran Expo

Not Confirmed

envelop Contact Supplier
Kookjeon Pharmaceutical Co., Ltd.
2020-07-16
20200716-211-J-434
ICE SPA@Raichem Medicare ...
Italy
Via Sicilia, 8-10-42122 R...
URL Supplier Web Content
Samo Pharmaceutical Co., Ltd.
2023-08-08
20230808-211-J-1475
Shilpa Pharma Lifescience...
India
Plot No. 33, 33A, 40 to 4...
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Daesin Pharmaceutical Co., Ltd.
2023-01-10
20210723-211-J-885(6)
Suzhou Tianlu Bio-pharmac...
China
1128 Yin Zhong South Road...
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Fine Farm Co., Ltd.
2022-08-05
20210723-211-J-885(5)
Suzhou Tianlu Bio-Pharmac...
China
1128 Yinzhong South Road ...
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Sanil Pharmaceutical Co., Ltd.
2022-08-04
20210723-211-J-885(2)
Suzhou Tianlu Bio-pharmac...
China
1128 Yin Zhong South Road...
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JSP Co., Ltd.
2022-08-04
20210723-211-J-885(3)
Suzhou Tianlu Bio-Pharmac...
China
1128 Yin Zhong South Road...
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Ace Biopharm Co., Ltd.
2022-08-04
20210723-211-J-885(4)
Suzhou Tianlu Bio-pharmac...
China
1128 Yin Zhong South Road...
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SG Biochem Co., Ltd.
2023-12-07
20210723-211-J-885(7)
Suzhou Tianlu Bio-pharmac...
China
1128 Yin Zhong South Road...
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Pampia Co., Ltd.
2023-03-07
20230307-211-J-1457
Zhongshan Belling Biotech...
China
No.28 Jiuzhou Road, Torch...
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Looking for 128-13-2 / Ursodeoxycholic Acid API manufacturers, exporters & distributors?

Ursodeoxycholic Acid manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ursodeoxycholic Acid

Synonyms

Ursodiol, 128-13-2, Actigall, Ursodeoxycholate, Udca, Ursofalk

Cas Number

128-13-2

Unique Ingredient Identifier (UNII)

724L30Y2QR

About Ursodeoxycholic Acid

An epimer of chenodeoxycholic acid. It is a mammalian bile acid found first in the bear and is apparently either a precursor or a product of chenodeoxycholate. Its administration changes the composition of bile and may dissolve gallstones. It is used as a cholagogue and choleretic.

Ursodiol Manufacturers

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

Ursodiol Suppliers

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

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

Ursodiol KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Ursodiol Drug Master File in Korea (Ursodiol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ursodiol. The MFDS reviews the Ursodiol KDMF as part of the drug registration process and uses the information provided in the Ursodiol KDMF to evaluate the safety and efficacy of the drug.

After submitting a Ursodiol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ursodiol API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Ursodiol suppliers with KDMF on PharmaCompass.

Ursodiol Manufacturers | Traders | Suppliers

Ursodiol Manufacturers, Traders, Suppliers 1
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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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