ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
01 1ICE Pharma
02 1Sichuan Elixir Pharmaceuticals
03 1ALP Pharm
04 1Adare Pharma Solutions
05 1Arch Pharmalabs
06 3Daewoong Pharmaceutical
07 1Dipharma
08 1Erregierre SpA
09 1F. Hoffmann-La Roche
10 1FALK & Co
11 1Giuliani
12 1Glenmark Life Sciences
13 1Mitsubishi Tanabe Pharma
14 2Sichuan Xieli Pharmaceutical
15 1Solara Active Pharma Sciences
16 1Solvay Chemicals International S.A
17 1Zhongshan Belling Biotechnology
18 3Blank
01 1TAUROURSODEOXYCHOLIC ACID
02 7URSODEOXYCHOLIC ACID
03 1URSODEOXYCHOLIC ACID (URSOFALK CAPS)
04 1URSODEOXYCHOLIC ACID (250MG. TABLETS)
05 1URSODEOXYCHOLIC ACID (DRUG SUBSTANCE NON-STERILE)
06 1URSODEOXYCHOLIC ACID (RO13-1798)
07 1URSODEOXYCHOLIC ACID (URSODIOL)
08 1URSODEOXYCHOLIC ACID 250 MG TABLETS
09 3URSODIOL
10 1URSODIOL SUSPENSION, 250 MG/ML
11 2URSODIOL USP
12 1URSODIOL USP (PROCESS I)
13 1URSODIOL USP (PROCESS IV)
14 1URSODIOL USP (URSODEOXYCHOLIC ACID)
01 1Australia
02 1Belgium
03 5China
04 3India
05 4Italy
06 1Japan
07 3South Korea
08 1Switzerland
09 1U.S.A
10 3Blank
01 11Active
02 12Inactive
01 5Complete
02 18Blank
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-25
Pay. Date : 2019-02-14
DMF Number : 16803
Submission : 2003-09-03
Status : Active
Type : II
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39647
Submission : 2024-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-25
Pay. Date : 2020-12-24
DMF Number : 33410
Submission : 2018-12-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-10
Pay. Date : 2015-02-02
DMF Number : 28994
Submission : 2015-02-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-08
Pay. Date : 2014-12-23
DMF Number : 25536
Submission : 2011-11-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-07
Pay. Date : 2015-04-09
DMF Number : 11379
Submission : 1995-03-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31987
Submission : 2017-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3312
Submission : 1978-08-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31403
Submission : 2017-06-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34937
Submission : 2020-11-30
Status : Active
Type : II
A Ursodeoxycholic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ursodeoxycholic Acid, including repackagers and relabelers. The FDA regulates Ursodeoxycholic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ursodeoxycholic 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 Ursodeoxycholic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ursodeoxycholic Acid supplier is an individual or a company that provides Ursodeoxycholic Acid active pharmaceutical ingredient (API) or Ursodeoxycholic Acid finished formulations upon request. The Ursodeoxycholic Acid suppliers may include Ursodeoxycholic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Ursodeoxycholic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ursodeoxycholic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Ursodeoxycholic Acid active pharmaceutical ingredient (API) in detail. Different forms of Ursodeoxycholic Acid DMFs exist exist since differing nations have different regulations, such as Ursodeoxycholic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ursodeoxycholic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Ursodeoxycholic Acid USDMF includes data on Ursodeoxycholic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ursodeoxycholic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ursodeoxycholic Acid suppliers with USDMF on PharmaCompass.
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