Synopsis
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-28
Pay. Date : 2013-09-18
DMF Number : 1748
Submission : 1971-06-21
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2736
Submission : 1976-07-19
Status :
Type : II
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-06
Pay. Date : 2013-02-14
DMF Number : 4524
Submission : 1982-05-10
Status :
Type : II
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12127
Submission : 1996-09-11
Status :
Type : II
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4532
Submission : 1982-05-10
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-26
Pay. Date : 2023-10-03
DMF Number : 38162
Submission : 2023-03-29
Status :
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-09
Pay. Date : 2018-03-15
DMF Number : 31532
Submission : 2017-03-10
Status :
Type : II
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Drugs in Development
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DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.1%
USFDA APPLICATION NUMBER - 13422
DOSAGE - SUSPENSION/DROPS;OTIC - 0.3%;0.1%
USFDA APPLICATION NUMBER - 21537
DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG ...DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
USFDA APPLICATION NUMBER - 50065
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.1%;0...DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.1%;0.3%
USFDA APPLICATION NUMBER - 50592
DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;0.3%
USFDA APPLICATION NUMBER - 50616
DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.05%;...DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.05%;0.3%
USFDA APPLICATION NUMBER - 50818
DOSAGE - TABLET;ORAL - 1.5MG
USFDA APPLICATION NUMBER - 84610
DOSAGE - TABLET;ORAL - 0.5MG
USFDA APPLICATION NUMBER - 84611
DOSAGE - TABLET;ORAL - 4MG
USFDA APPLICATION NUMBER - 84612
DOSAGE - TABLET;ORAL - 0.75MG
USFDA APPLICATION NUMBER - 84613
DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 87916
DOSAGE - SOLUTION;ORAL - 0.5MG/5ML
USFDA APPLICATION NUMBER - 88248
DOSAGE - ELIXIR;ORAL - 0.5MG/5ML
USFDA APPLICATION NUMBER - 88254
DOSAGE - TABLET;ORAL - 1MG
USFDA APPLICATION NUMBER - 88306
DOSAGE - TABLET;ORAL - 6MG
USFDA APPLICATION NUMBER - 88316
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USP
ANALYTICAL
ABOUT THIS PAGE
A .gamma.corten manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of .gamma.corten, including repackagers and relabelers. The FDA regulates .gamma.corten manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. .gamma.corten 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 .gamma.corten manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A .gamma.corten supplier is an individual or a company that provides .gamma.corten active pharmaceutical ingredient (API) or .gamma.corten finished formulations upon request. The .gamma.corten suppliers may include .gamma.corten API manufacturers, exporters, distributors and traders.
click here to find a list of .gamma.corten suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A .gamma.corten DMF (Drug Master File) is a document detailing the whole manufacturing process of .gamma.corten active pharmaceutical ingredient (API) in detail. Different forms of .gamma.corten DMFs exist exist since differing nations have different regulations, such as .gamma.corten USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A .gamma.corten DMF submitted to regulatory agencies in the US is known as a USDMF. .gamma.corten USDMF includes data on .gamma.corten's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The .gamma.corten USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of .gamma.corten 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 .gamma.corten Drug Master File in Japan (.gamma.corten JDMF) empowers .gamma.corten 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 .gamma.corten JDMF during the approval evaluation for pharmaceutical products. At the time of .gamma.corten 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 .gamma.corten 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 .gamma.corten Drug Master File in Korea (.gamma.corten KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of .gamma.corten. The MFDS reviews the .gamma.corten KDMF as part of the drug registration process and uses the information provided in the .gamma.corten KDMF to evaluate the safety and efficacy of the drug.
After submitting a .gamma.corten 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 .gamma.corten API can apply through the Korea Drug Master File (KDMF).
click here to find a list of .gamma.corten suppliers with KDMF on PharmaCompass.
A .gamma.corten CEP of the European Pharmacopoeia monograph is often referred to as a .gamma.corten Certificate of Suitability (COS). The purpose of a .gamma.corten CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of .gamma.corten EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of .gamma.corten to their clients by showing that a .gamma.corten CEP has been issued for it. The manufacturer submits a .gamma.corten CEP (COS) as part of the market authorization procedure, and it takes on the role of a .gamma.corten CEP holder for the record. Additionally, the data presented in the .gamma.corten CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the .gamma.corten DMF.
A .gamma.corten CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. .gamma.corten 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 .gamma.corten suppliers with CEP (COS) on PharmaCompass.
A .gamma.corten written confirmation (.gamma.corten WC) is an official document issued by a regulatory agency to a .gamma.corten manufacturer, verifying that the manufacturing facility of a .gamma.corten active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting .gamma.corten APIs or .gamma.corten finished pharmaceutical products to another nation, regulatory agencies frequently require a .gamma.corten WC (written confirmation) as part of the regulatory process.
click here to find a list of .gamma.corten 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 .gamma.corten as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for .gamma.corten 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 .gamma.corten 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 .gamma.corten and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a .gamma.corten NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of .gamma.corten suppliers with NDC on PharmaCompass.
.gamma.corten 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 .gamma.corten 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 .gamma.corten GMP manufacturer or .gamma.corten GMP API supplier for your needs.
A .gamma.corten CoA (Certificate of Analysis) is a formal document that attests to .gamma.corten's compliance with .gamma.corten specifications and serves as a tool for batch-level quality control.
.gamma.corten CoA mostly includes findings from lab analyses of a specific batch. For each .gamma.corten 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.
.gamma.corten may be tested according to a variety of international standards, such as European Pharmacopoeia (.gamma.corten EP), .gamma.corten JP (Japanese Pharmacopeia) and the US Pharmacopoeia (.gamma.corten USP).
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