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DRUG PRODUCT COMPOSITIONS0
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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,Inapplicable
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
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 : Miscellaneous
Upfront Cash : Inapplicable
January 25, 2021
Lead Product(s) : Ursodeoxycholic Acid,Inapplicable
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
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 : Miscellaneous
Upfront Cash : Inapplicable
August 21, 2020
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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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SPI Pharma has been solving formulation challenges using superior functional materials.
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DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
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Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
83
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 Antigall manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Antigall, including repackagers and relabelers. The FDA regulates Antigall manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Antigall 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 Antigall manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Antigall supplier is an individual or a company that provides Antigall active pharmaceutical ingredient (API) or Antigall finished formulations upon request. The Antigall suppliers may include Antigall API manufacturers, exporters, distributors and traders.
click here to find a list of Antigall suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Antigall DMF (Drug Master File) is a document detailing the whole manufacturing process of Antigall active pharmaceutical ingredient (API) in detail. Different forms of Antigall DMFs exist exist since differing nations have different regulations, such as Antigall USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Antigall DMF submitted to regulatory agencies in the US is known as a USDMF. Antigall USDMF includes data on Antigall's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Antigall USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Antigall 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 Antigall Drug Master File in Japan (Antigall JDMF) empowers Antigall 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 Antigall JDMF during the approval evaluation for pharmaceutical products. At the time of Antigall 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 Antigall 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 Antigall Drug Master File in Korea (Antigall KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Antigall. The MFDS reviews the Antigall KDMF as part of the drug registration process and uses the information provided in the Antigall KDMF to evaluate the safety and efficacy of the drug.
After submitting a Antigall 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 Antigall API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Antigall suppliers with KDMF on PharmaCompass.
A Antigall CEP of the European Pharmacopoeia monograph is often referred to as a Antigall Certificate of Suitability (COS). The purpose of a Antigall CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Antigall EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Antigall to their clients by showing that a Antigall CEP has been issued for it. The manufacturer submits a Antigall CEP (COS) as part of the market authorization procedure, and it takes on the role of a Antigall CEP holder for the record. Additionally, the data presented in the Antigall CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Antigall DMF.
A Antigall CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Antigall 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 Antigall suppliers with CEP (COS) on PharmaCompass.
A Antigall written confirmation (Antigall WC) is an official document issued by a regulatory agency to a Antigall manufacturer, verifying that the manufacturing facility of a Antigall active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Antigall APIs or Antigall finished pharmaceutical products to another nation, regulatory agencies frequently require a Antigall WC (written confirmation) as part of the regulatory process.
click here to find a list of Antigall 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 Antigall as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Antigall 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 Antigall 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 Antigall and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Antigall NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Antigall suppliers with NDC on PharmaCompass.
Antigall 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 Antigall 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 Antigall GMP manufacturer or Antigall GMP API supplier for your needs.
A Antigall CoA (Certificate of Analysis) is a formal document that attests to Antigall's compliance with Antigall specifications and serves as a tool for batch-level quality control.
Antigall CoA mostly includes findings from lab analyses of a specific batch. For each Antigall 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.
Antigall may be tested according to a variety of international standards, such as European Pharmacopoeia (Antigall EP), Antigall JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Antigall USP).
