Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
About the Company : ICE Pharma manufactures active pharmaceutical ingredients, with a core focus on Ursodeoxycholic Acid (UDCA) for the treatment of liver diseases and gallstones. The company also dev...
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, based in Indore, India, is a leading API manufacturer specializing in cortico-steroids and steroid-hormone APIs since 1995. Focused on R&D, sustainability, and innovatio...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfoli...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma was established in 1986 and began operating as a fully integrated pharmaceutical company in 1995. The company offers a broad portfolio across multiple therapeutic ca...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - CAPSULE;ORAL - 300MG
USFDA APPLICATION NUMBER - 19594
DOSAGE - TABLET;ORAL - 250MG
USFDA APPLICATION NUMBER - 20675
DOSAGE - TABLET;ORAL - 500MG
USFDA APPLICATION NUMBER - 20675
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Huzhou Sunflower Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vertellus
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Granulation
Controlled & Modified Release
Direct Compression
Thickeners and Stabilizers
Film Formers & Plasticizers
Solubilizers
Topical
Taste Masking
Disintegrants & Superdisintegrants
Lubricants & Glidants
Co-Processed Excipients
Chewable & Orodispersible Aids
Parenteral
Empty Capsules
Emulsifying Agents
API Stability Enhancers
Rheology Modifiers
Vegetarian Capsules
Surfactant & Foaming Agents
Coloring Agents
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
69
PharmaCompass offers a list of Ursodeoxycholic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A UDCA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of UDCA, including repackagers and relabelers. The FDA regulates UDCA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. UDCA 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 UDCA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A UDCA supplier is an individual or a company that provides UDCA active pharmaceutical ingredient (API) or UDCA finished formulations upon request. The UDCA suppliers may include UDCA API manufacturers, exporters, distributors and traders.
click here to find a list of UDCA suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A UDCA DMF (Drug Master File) is a document detailing the whole manufacturing process of UDCA active pharmaceutical ingredient (API) in detail. Different forms of UDCA DMFs exist exist since differing nations have different regulations, such as UDCA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A UDCA DMF submitted to regulatory agencies in the US is known as a USDMF. UDCA USDMF includes data on UDCA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The UDCA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of UDCA suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The UDCA Drug Master File in Japan (UDCA JDMF) empowers UDCA API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the UDCA JDMF during the approval evaluation for pharmaceutical products. At the time of UDCA JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of UDCA suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a UDCA Drug Master File in Korea (UDCA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of UDCA. The MFDS reviews the UDCA KDMF as part of the drug registration process and uses the information provided in the UDCA KDMF to evaluate the safety and efficacy of the drug.
After submitting a UDCA 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 UDCA API can apply through the Korea Drug Master File (KDMF).
click here to find a list of UDCA suppliers with KDMF on PharmaCompass.
A UDCA CEP of the European Pharmacopoeia monograph is often referred to as a UDCA Certificate of Suitability (COS). The purpose of a UDCA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of UDCA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of UDCA to their clients by showing that a UDCA CEP has been issued for it. The manufacturer submits a UDCA CEP (COS) as part of the market authorization procedure, and it takes on the role of a UDCA CEP holder for the record. Additionally, the data presented in the UDCA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the UDCA DMF.
A UDCA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. UDCA CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of UDCA suppliers with CEP (COS) on PharmaCompass.
A UDCA written confirmation (UDCA WC) is an official document issued by a regulatory agency to a UDCA manufacturer, verifying that the manufacturing facility of a UDCA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting UDCA APIs or UDCA finished pharmaceutical products to another nation, regulatory agencies frequently require a UDCA WC (written confirmation) as part of the regulatory process.
click here to find a list of UDCA suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing UDCA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for UDCA API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture UDCA as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain UDCA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a UDCA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of UDCA suppliers with NDC on PharmaCompass.
UDCA Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of UDCA GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right UDCA GMP manufacturer or UDCA GMP API supplier for your needs.
A UDCA CoA (Certificate of Analysis) is a formal document that attests to UDCA's compliance with UDCA specifications and serves as a tool for batch-level quality control.
UDCA CoA mostly includes findings from lab analyses of a specific batch. For each UDCA CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
UDCA may be tested according to a variety of international standards, such as European Pharmacopoeia (UDCA EP), UDCA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (UDCA USP).
