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API SUPPLIERS
Axplora is your partner of choice for complex APIs.
JDMF
KDMF
EU, BR 
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
CEP/COS
JDMF
EU-WC
NDC
KDMF
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
Axplora is your partner of choice for complex APIs.
EU, BR
Axplora is your partner of choice for complex APIs.
EU, BR
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
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USDMF
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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...
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
About the Company : ICE Pharma's core business includes the manufacture of active pharmaceutical ingredients, the most important of which is Ursodeoxycholic Acid (UDCA), used to treat liver diseases a...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...
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 expertise in formulation development, manufacturing, and commercialization. Our portfolio...
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
About the Company : Zeal MediPharma is a globally recognized Star One Export House, serving customers in over 50 countries for more than two decades. We specialize in sourcing and exporting high-quali...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical com...
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API Imports and Exports
Drugs in Development
Lead Product(s) : Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Strides Receives USFDA Approval for Ursodiol Capsules
Details : Strides Pharma, has received approval for Ursodiol Capsules USP, 300 mg from the USFDA. The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Actigall® Capsules, 300 mg, of Allergan Sales, LLC.
Product Name : Urso Forte-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 25, 2021
Lead Product(s) : Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Strides Receives USFDA Approval for Ursodiol Tablets
Details : USFDA approved generic version of Ursodiol Tablet, which is indicated for the treatment of patients with Primary Biliary Cirrhosis. It inhibits the absorption of cholesterol in the intestine and the secretion of cholesterol into bile, decreasing biliary ...
Product Name : Urso Forte-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 21, 2020
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Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Ursodeoxycholic Acid
Dosage Form : Capsule
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Ursodeoxycholic Acid
Dosage Form : Capsule
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Ursodeoxycholic Acid
Dosage Form : Capsule
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Ursodeoxycholic Acid
Dosage Form : Tablet
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Ursodeoxycholic Acid
Dosage Form : Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Ursodeoxycholic Acid
Dosage Form : Capsule
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Ursodeoxycholic Acid
Dosage Form : Capsule
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Ursodeoxycholic Acid
Dosage Form : DC Granules
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Ursodeoxycholic Acid
Dosage Form : DC Granules
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Ursodeoxycholic Acid
Dosage Form : Tablet
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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DOSAGE - CAPSULE;ORAL - 300MG
USFDA APPLICATION NUMBER - 19594
DOSAGE - TABLET;ORAL - 250MG
USFDA APPLICATION NUMBER - 20675
DOSAGE - TABLET;ORAL - 500MG
USFDA APPLICATION NUMBER - 20675
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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.
A Acidum ursodeoxycholicum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acidum ursodeoxycholicum, including repackagers and relabelers. The FDA regulates Acidum ursodeoxycholicum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acidum ursodeoxycholicum 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 Acidum ursodeoxycholicum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acidum ursodeoxycholicum supplier is an individual or a company that provides Acidum ursodeoxycholicum active pharmaceutical ingredient (API) or Acidum ursodeoxycholicum finished formulations upon request. The Acidum ursodeoxycholicum suppliers may include Acidum ursodeoxycholicum API manufacturers, exporters, distributors and traders.
click here to find a list of Acidum ursodeoxycholicum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acidum ursodeoxycholicum DMF (Drug Master File) is a document detailing the whole manufacturing process of Acidum ursodeoxycholicum active pharmaceutical ingredient (API) in detail. Different forms of Acidum ursodeoxycholicum DMFs exist exist since differing nations have different regulations, such as Acidum ursodeoxycholicum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acidum ursodeoxycholicum DMF submitted to regulatory agencies in the US is known as a USDMF. Acidum ursodeoxycholicum USDMF includes data on Acidum ursodeoxycholicum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acidum ursodeoxycholicum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acidum ursodeoxycholicum 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 Acidum ursodeoxycholicum Drug Master File in Japan (Acidum ursodeoxycholicum JDMF) empowers Acidum ursodeoxycholicum 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 Acidum ursodeoxycholicum JDMF during the approval evaluation for pharmaceutical products. At the time of Acidum ursodeoxycholicum 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 Acidum ursodeoxycholicum 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 Acidum ursodeoxycholicum Drug Master File in Korea (Acidum ursodeoxycholicum KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Acidum ursodeoxycholicum. The MFDS reviews the Acidum ursodeoxycholicum KDMF as part of the drug registration process and uses the information provided in the Acidum ursodeoxycholicum KDMF to evaluate the safety and efficacy of the drug.
After submitting a Acidum ursodeoxycholicum 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 Acidum ursodeoxycholicum API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Acidum ursodeoxycholicum suppliers with KDMF on PharmaCompass.
A Acidum ursodeoxycholicum CEP of the European Pharmacopoeia monograph is often referred to as a Acidum ursodeoxycholicum Certificate of Suitability (COS). The purpose of a Acidum ursodeoxycholicum CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Acidum ursodeoxycholicum EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Acidum ursodeoxycholicum to their clients by showing that a Acidum ursodeoxycholicum CEP has been issued for it. The manufacturer submits a Acidum ursodeoxycholicum CEP (COS) as part of the market authorization procedure, and it takes on the role of a Acidum ursodeoxycholicum CEP holder for the record. Additionally, the data presented in the Acidum ursodeoxycholicum CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Acidum ursodeoxycholicum DMF.
A Acidum ursodeoxycholicum CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Acidum ursodeoxycholicum 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 Acidum ursodeoxycholicum suppliers with CEP (COS) on PharmaCompass.
A Acidum ursodeoxycholicum written confirmation (Acidum ursodeoxycholicum WC) is an official document issued by a regulatory agency to a Acidum ursodeoxycholicum manufacturer, verifying that the manufacturing facility of a Acidum ursodeoxycholicum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Acidum ursodeoxycholicum APIs or Acidum ursodeoxycholicum finished pharmaceutical products to another nation, regulatory agencies frequently require a Acidum ursodeoxycholicum WC (written confirmation) as part of the regulatory process.
click here to find a list of Acidum ursodeoxycholicum 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 Acidum ursodeoxycholicum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Acidum ursodeoxycholicum 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 Acidum ursodeoxycholicum 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 Acidum ursodeoxycholicum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acidum ursodeoxycholicum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Acidum ursodeoxycholicum suppliers with NDC on PharmaCompass.
Acidum ursodeoxycholicum 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 Acidum ursodeoxycholicum GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Acidum ursodeoxycholicum GMP manufacturer or Acidum ursodeoxycholicum GMP API supplier for your needs.
A Acidum ursodeoxycholicum CoA (Certificate of Analysis) is a formal document that attests to Acidum ursodeoxycholicum's compliance with Acidum ursodeoxycholicum specifications and serves as a tool for batch-level quality control.
Acidum ursodeoxycholicum CoA mostly includes findings from lab analyses of a specific batch. For each Acidum ursodeoxycholicum 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.
Acidum ursodeoxycholicum may be tested according to a variety of international standards, such as European Pharmacopoeia (Acidum ursodeoxycholicum EP), Acidum ursodeoxycholicum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acidum ursodeoxycholicum USP).
