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API SUPPLIERS
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NDC
EU
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
CA, ASMF
Human Pharmalabs manufacturer of high quality corticosteroid APIs with a state of the art facility in Kalol Gandhinagar.
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USDMF
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GDUFA
DMF Review : Complete
Rev. Date : 2014-08-27
Pay. Date : 2014-04-14
DMF Number : 25228
Submission : 2011-08-23
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-26
Pay. Date : 2015-10-21
DMF Number : 19870
Submission : 2006-10-16
Status :
Type : II
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API Imports and Exports
Drugs in Development
Lead Product(s) : Difluprednate,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Difluprednate is a topical corticosteroid for inflammation and pain associated with ocular surgery.It is thought to induce phospholipase A2 inhibitory proteins, which controls the biosynthesis of potent mediators of infammation by inhibiting the release ...
Product Name : Difluprednate-Generic
Product Type : Steroid
Upfront Cash : Inapplicable
January 27, 2023
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ABOUT THIS PAGE
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PharmaCompass offers a list of Difluprednate 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 Difluprednate manufacturer or Difluprednate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Difluprednate manufacturer or Difluprednate supplier.
PharmaCompass also assists you with knowing the Difluprednate API Price utilized in the formulation of products. Difluprednate API Price is not always fixed or binding as the Difluprednate Price is obtained through a variety of data sources. The Difluprednate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Difluprednate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Difluprednate, including repackagers and relabelers. The FDA regulates Difluprednate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Difluprednate 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 Difluprednate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Difluprednate supplier is an individual or a company that provides Difluprednate active pharmaceutical ingredient (API) or Difluprednate finished formulations upon request. The Difluprednate suppliers may include Difluprednate API manufacturers, exporters, distributors and traders.
click here to find a list of Difluprednate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Difluprednate DMF (Drug Master File) is a document detailing the whole manufacturing process of Difluprednate active pharmaceutical ingredient (API) in detail. Different forms of Difluprednate DMFs exist exist since differing nations have different regulations, such as Difluprednate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Difluprednate DMF submitted to regulatory agencies in the US is known as a USDMF. Difluprednate USDMF includes data on Difluprednate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Difluprednate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Difluprednate 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 Difluprednate Drug Master File in Japan (Difluprednate JDMF) empowers Difluprednate 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 Difluprednate JDMF during the approval evaluation for pharmaceutical products. At the time of Difluprednate 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 Difluprednate suppliers with JDMF on PharmaCompass.
A Difluprednate written confirmation (Difluprednate WC) is an official document issued by a regulatory agency to a Difluprednate manufacturer, verifying that the manufacturing facility of a Difluprednate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Difluprednate APIs or Difluprednate finished pharmaceutical products to another nation, regulatory agencies frequently require a Difluprednate WC (written confirmation) as part of the regulatory process.
click here to find a list of Difluprednate 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 Difluprednate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Difluprednate 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 Difluprednate 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 Difluprednate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Difluprednate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Difluprednate suppliers with NDC on PharmaCompass.
Difluprednate 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 Difluprednate 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 Difluprednate GMP manufacturer or Difluprednate GMP API supplier for your needs.
A Difluprednate CoA (Certificate of Analysis) is a formal document that attests to Difluprednate's compliance with Difluprednate specifications and serves as a tool for batch-level quality control.
Difluprednate CoA mostly includes findings from lab analyses of a specific batch. For each Difluprednate 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.
Difluprednate may be tested according to a variety of international standards, such as European Pharmacopoeia (Difluprednate EP), Difluprednate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Difluprednate USP).
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