Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
US Patents
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US Exclusivities
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Health Canada Patents
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
CEP/COS 
JDMF
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
CEP/COS
EU-WC
NDC
Axplora is your partner of choice for complex APIs.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
JDMF
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Axplora is your partner of choice for complex APIs.
Axplora is your partner of choice for complex APIs.
Axplora is your partner of choice for complex APIs.
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USDMF
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-18
Pay. Date : 2013-02-14
DMF Number : 5498
Submission : 1984-06-11
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-15
Pay. Date : 2016-10-27
DMF Number : 30820
Submission : 2016-08-05
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
Hydrocortisone Acetate, Micronised
Certificate Number : CEP 2002-160 - Rev 05
Status : Valid
Issue Date : 2024-12-11
Type : Chemical
Substance Number : 334
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Hydrocortisone Acetate, Micronised, Grades I And...
Certificate Number : CEP 2016-228 - Rev 02
Status : Valid
Issue Date : 2023-10-27
Type : Chemical
Substance Number : 334
Axplora is your partner of choice for complex APIs.
Certificate Number : R0-CEP 2018-171 - Rev 00
Status : Valid
Issue Date : 2020-06-15
Type : Chemical
Substance Number : 334
Axplora is your partner of choice for complex APIs.
Certificate Number : R0-CEP 2020-135 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2020-06-15
Type : Chemical
Substance Number : 334
Axplora is your partner of choice for complex APIs.
Hydrocortisone Acetate, Micronised, Sterile
Certificate Number : R0-CEP 2021-456 - Rev 00
Status : Valid
Issue Date : 2023-04-18
Type : Chemical
Substance Number : 334
Axplora is your partner of choice for complex APIs.
Hydrocortisone Acetate, Micronised, Alternative ...
Certificate Number : CEP 2024-068 - Rev 00
Status : Valid
Issue Date : 2024-07-31
Type : Chemical
Substance Number : 334
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Hydrocortisone Acetate, Micronised
Certificate Number : CEP 1996-053 - Rev 09
Status : Valid
Issue Date : 2024-06-26
Type : Chemical
Substance Number : 334
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Hydrocortisone Acetate, Process 2
Certificate Number : R1-CEP 2012-355 - Rev 01
Status : Valid
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 334
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
FDF Dossiers
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DOSAGE - AEROSOL, METERED;RECTAL - 10%
USFDA APPLICATION NUMBER - 17351
DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/G...DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50218
DOSAGE - SUSPENSION/DROPS;OTIC - EQ 3MG BASE/...DOSAGE - SUSPENSION/DROPS;OTIC - EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML
USFDA APPLICATION NUMBER - 50356
DOSAGE - AEROSOL, METERED;TOPICAL - 1%;1%
USFDA APPLICATION NUMBER - 86195
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EUROAPI
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Topical
Coating Systems & Additives
Solubilizers
Thickeners and Stabilizers
Controlled & Modified Release
Fillers, Diluents & Binders
Parenteral
Film Formers & Plasticizers
Emulsifying Agents
Taste Masking
Granulation
Surfactant & Foaming Agents
Direct Compression
Lubricants & Glidants
Co-Processed Excipients
Rheology Modifiers
API Stability Enhancers
Chewable & Orodispersible Aids
Empty Capsules
Vegetarian Capsules
Coloring Agents
Disintegrants & Superdisintegrants
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Hydrocortisone Acetate 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 Hydrocortisone Acetate manufacturer or Hydrocortisone Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydrocortisone Acetate manufacturer or Hydrocortisone Acetate supplier.
PharmaCompass also assists you with knowing the Hydrocortisone Acetate API Price utilized in the formulation of products. Hydrocortisone Acetate API Price is not always fixed or binding as the Hydrocortisone Acetate Price is obtained through a variety of data sources. The Hydrocortisone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1%, including repackagers and relabelers. The FDA regulates HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% 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 HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% supplier is an individual or a company that provides HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% active pharmaceutical ingredient (API) or HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% finished formulations upon request. The HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% suppliers may include HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% API manufacturers, exporters, distributors and traders.
click here to find a list of HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% DMF (Drug Master File) is a document detailing the whole manufacturing process of HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% active pharmaceutical ingredient (API) in detail. Different forms of HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% DMFs exist exist since differing nations have different regulations, such as HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% DMF submitted to regulatory agencies in the US is known as a USDMF. HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% USDMF includes data on HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1%'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% 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 HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% Drug Master File in Japan (HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% JDMF) empowers HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% 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 HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% JDMF during the approval evaluation for pharmaceutical products. At the time of HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% 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 HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% 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 HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% Drug Master File in Korea (HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1%. The MFDS reviews the HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% KDMF as part of the drug registration process and uses the information provided in the HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% KDMF to evaluate the safety and efficacy of the drug.
After submitting a HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% 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 HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% API can apply through the Korea Drug Master File (KDMF).
click here to find a list of HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% suppliers with KDMF on PharmaCompass.
A HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% CEP of the European Pharmacopoeia monograph is often referred to as a HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% Certificate of Suitability (COS). The purpose of a HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% to their clients by showing that a HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% CEP has been issued for it. The manufacturer submits a HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% CEP (COS) as part of the market authorization procedure, and it takes on the role of a HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% CEP holder for the record. Additionally, the data presented in the HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% DMF.
A HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% 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 HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% suppliers with CEP (COS) on PharmaCompass.
A HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% written confirmation (HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% WC) is an official document issued by a regulatory agency to a HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% manufacturer, verifying that the manufacturing facility of a HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% APIs or HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% finished pharmaceutical products to another nation, regulatory agencies frequently require a HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% WC (written confirmation) as part of the regulatory process.
click here to find a list of HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% 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 HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% 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 HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% 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 HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% suppliers with NDC on PharmaCompass.
HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% 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 HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% 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 HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% GMP manufacturer or HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% GMP API supplier for your needs.
A HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% CoA (Certificate of Analysis) is a formal document that attests to HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1%'s compliance with HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% specifications and serves as a tool for batch-level quality control.
HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% CoA mostly includes findings from lab analyses of a specific batch. For each HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% 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.
HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% may be tested according to a variety of international standards, such as European Pharmacopoeia (HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% EP), HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% JP (Japanese Pharmacopeia) and the US Pharmacopoeia (HYDROCORTISONE ACETATE 1%; PRAMOXINE HYDROCHLORIDE 1% USP).
