Synopsis
0
JDMF
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
SPI Pharma
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]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]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]Gangwal Chemicals
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]Ingredion Pharma Solutions
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]Neelkanth MineChem
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]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]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]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Granulation
Direct Compression
Controlled & Modified Release
Lubricants & Glidants
Disintegrants & Superdisintegrants
Thickeners and Stabilizers
Film Formers & Plasticizers
Co-Processed Excipients
Taste Masking
Chewable & Orodispersible Aids
Parenteral
Solubilizers
Empty Capsules
Emulsifying Agents
Vegetarian Capsules
API Stability Enhancers
Rheology Modifiers
Coloring Agents
Topical
Surfactant & Foaming Agents
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
13
PharmaCompass offers a list of Orphenadrine 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 Orphenadrine manufacturer or Orphenadrine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Orphenadrine manufacturer or Orphenadrine supplier.
A Norflex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Norflex, including repackagers and relabelers. The FDA regulates Norflex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Norflex 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 Norflex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Norflex supplier is an individual or a company that provides Norflex active pharmaceutical ingredient (API) or Norflex finished formulations upon request. The Norflex suppliers may include Norflex API manufacturers, exporters, distributors and traders.
click here to find a list of Norflex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Norflex DMF (Drug Master File) is a document detailing the whole manufacturing process of Norflex active pharmaceutical ingredient (API) in detail. Different forms of Norflex DMFs exist exist since differing nations have different regulations, such as Norflex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Norflex DMF submitted to regulatory agencies in the US is known as a USDMF. Norflex USDMF includes data on Norflex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Norflex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Norflex suppliers with USDMF 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 Norflex Drug Master File in Korea (Norflex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Norflex. The MFDS reviews the Norflex KDMF as part of the drug registration process and uses the information provided in the Norflex KDMF to evaluate the safety and efficacy of the drug.
After submitting a Norflex 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 Norflex API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Norflex suppliers with KDMF on PharmaCompass.
A Norflex CEP of the European Pharmacopoeia monograph is often referred to as a Norflex Certificate of Suitability (COS). The purpose of a Norflex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Norflex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Norflex to their clients by showing that a Norflex CEP has been issued for it. The manufacturer submits a Norflex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Norflex CEP holder for the record. Additionally, the data presented in the Norflex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Norflex DMF.
A Norflex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Norflex 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 Norflex suppliers with CEP (COS) on PharmaCompass.
A Norflex written confirmation (Norflex WC) is an official document issued by a regulatory agency to a Norflex manufacturer, verifying that the manufacturing facility of a Norflex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Norflex APIs or Norflex finished pharmaceutical products to another nation, regulatory agencies frequently require a Norflex WC (written confirmation) as part of the regulatory process.
click here to find a list of Norflex 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 Norflex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Norflex 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 Norflex 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 Norflex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Norflex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Norflex suppliers with NDC on PharmaCompass.
Norflex 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 Norflex GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Norflex GMP manufacturer or Norflex GMP API supplier for your needs.
A Norflex CoA (Certificate of Analysis) is a formal document that attests to Norflex's compliance with Norflex specifications and serves as a tool for batch-level quality control.
Norflex CoA mostly includes findings from lab analyses of a specific batch. For each Norflex 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.
Norflex may be tested according to a variety of international standards, such as European Pharmacopoeia (Norflex EP), Norflex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Norflex USP).
