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KDMF
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DRUG PRODUCT COMPOSITIONS
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Stock Recap #PipelineProspector
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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Cerata Pharmaceuticals LLP
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gloria Interchem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Symrise
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Topical
Fillers, Diluents & Binders
Solubilizers
Parenteral
Thickeners and Stabilizers
Film Formers & Plasticizers
Controlled & Modified Release
API Stability Enhancers
Direct Compression
Granulation
Co-Processed Excipients
Taste Masking
Surfactant & Foaming Agents
Rheology Modifiers
Disintegrants & Superdisintegrants
Emulsifying Agents
Chewable & Orodispersible Aids
Empty Capsules
Vegetarian Capsules
Lubricants & Glidants
Coloring Agents
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
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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 Oxymetazoline Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Oxymetazoline Hydrochloride manufacturer or Oxymetazoline Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oxymetazoline Hydrochloride manufacturer or Oxymetazoline Hydrochloride supplier.
A RHOFADE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of RHOFADE, including repackagers and relabelers. The FDA regulates RHOFADE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. RHOFADE 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 RHOFADE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A RHOFADE supplier is an individual or a company that provides RHOFADE active pharmaceutical ingredient (API) or RHOFADE finished formulations upon request. The RHOFADE suppliers may include RHOFADE API manufacturers, exporters, distributors and traders.
click here to find a list of RHOFADE suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A RHOFADE DMF (Drug Master File) is a document detailing the whole manufacturing process of RHOFADE active pharmaceutical ingredient (API) in detail. Different forms of RHOFADE DMFs exist exist since differing nations have different regulations, such as RHOFADE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A RHOFADE DMF submitted to regulatory agencies in the US is known as a USDMF. RHOFADE USDMF includes data on RHOFADE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The RHOFADE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of RHOFADE 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 RHOFADE Drug Master File in Japan (RHOFADE JDMF) empowers RHOFADE 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 RHOFADE JDMF during the approval evaluation for pharmaceutical products. At the time of RHOFADE 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 RHOFADE suppliers with JDMF on PharmaCompass.
A RHOFADE CEP of the European Pharmacopoeia monograph is often referred to as a RHOFADE Certificate of Suitability (COS). The purpose of a RHOFADE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of RHOFADE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of RHOFADE to their clients by showing that a RHOFADE CEP has been issued for it. The manufacturer submits a RHOFADE CEP (COS) as part of the market authorization procedure, and it takes on the role of a RHOFADE CEP holder for the record. Additionally, the data presented in the RHOFADE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the RHOFADE DMF.
A RHOFADE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. RHOFADE 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 RHOFADE suppliers with CEP (COS) on PharmaCompass.
A RHOFADE written confirmation (RHOFADE WC) is an official document issued by a regulatory agency to a RHOFADE manufacturer, verifying that the manufacturing facility of a RHOFADE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting RHOFADE APIs or RHOFADE finished pharmaceutical products to another nation, regulatory agencies frequently require a RHOFADE WC (written confirmation) as part of the regulatory process.
click here to find a list of RHOFADE 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 RHOFADE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for RHOFADE 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 RHOFADE 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 RHOFADE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a RHOFADE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of RHOFADE suppliers with NDC on PharmaCompass.
RHOFADE 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 RHOFADE GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right RHOFADE GMP manufacturer or RHOFADE GMP API supplier for your needs.
A RHOFADE CoA (Certificate of Analysis) is a formal document that attests to RHOFADE's compliance with RHOFADE specifications and serves as a tool for batch-level quality control.
RHOFADE CoA mostly includes findings from lab analyses of a specific batch. For each RHOFADE 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.
RHOFADE may be tested according to a variety of international standards, such as European Pharmacopoeia (RHOFADE EP), RHOFADE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (RHOFADE USP).
