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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
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NDC
KDMF
ASMF
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
EU-WC
NDC
ASMF
Jai Radhe Sales is your partner for all your sourcing needs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
ASMF
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USDMF
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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DOSAGE - TABLET;ORAL - EQ 2MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20397
DOSAGE - TABLET;ORAL - EQ 4MG BASE
USFDA APPLICATION NUMBER - 20397
DOSAGE - CAPSULE;ORAL - EQ 2MG BASE
USFDA APPLICATION NUMBER - 21447
DOSAGE - CAPSULE;ORAL - EQ 4MG BASE
USFDA APPLICATION NUMBER - 21447
DOSAGE - CAPSULE;ORAL - EQ 6MG BASE
USFDA APPLICATION NUMBER - 21447
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Evonik
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Tizanidine HCl 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 Tizanidine HCl manufacturer or Tizanidine HCl supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tizanidine HCl manufacturer or Tizanidine HCl supplier.
PharmaCompass also assists you with knowing the Tizanidine HCl API Price utilized in the formulation of products. Tizanidine HCl API Price is not always fixed or binding as the Tizanidine HCl Price is obtained through a variety of data sources. The Tizanidine HCl Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Zanaflex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zanaflex, including repackagers and relabelers. The FDA regulates Zanaflex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zanaflex 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 Zanaflex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zanaflex supplier is an individual or a company that provides Zanaflex active pharmaceutical ingredient (API) or Zanaflex finished formulations upon request. The Zanaflex suppliers may include Zanaflex API manufacturers, exporters, distributors and traders.
click here to find a list of Zanaflex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zanaflex DMF (Drug Master File) is a document detailing the whole manufacturing process of Zanaflex active pharmaceutical ingredient (API) in detail. Different forms of Zanaflex DMFs exist exist since differing nations have different regulations, such as Zanaflex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zanaflex DMF submitted to regulatory agencies in the US is known as a USDMF. Zanaflex USDMF includes data on Zanaflex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zanaflex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zanaflex 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 Zanaflex Drug Master File in Japan (Zanaflex JDMF) empowers Zanaflex 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 Zanaflex JDMF during the approval evaluation for pharmaceutical products. At the time of Zanaflex 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 Zanaflex 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 Zanaflex Drug Master File in Korea (Zanaflex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zanaflex. The MFDS reviews the Zanaflex KDMF as part of the drug registration process and uses the information provided in the Zanaflex KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zanaflex 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 Zanaflex API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zanaflex suppliers with KDMF on PharmaCompass.
A Zanaflex CEP of the European Pharmacopoeia monograph is often referred to as a Zanaflex Certificate of Suitability (COS). The purpose of a Zanaflex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zanaflex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zanaflex to their clients by showing that a Zanaflex CEP has been issued for it. The manufacturer submits a Zanaflex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zanaflex CEP holder for the record. Additionally, the data presented in the Zanaflex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zanaflex DMF.
A Zanaflex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zanaflex 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 Zanaflex suppliers with CEP (COS) on PharmaCompass.
A Zanaflex written confirmation (Zanaflex WC) is an official document issued by a regulatory agency to a Zanaflex manufacturer, verifying that the manufacturing facility of a Zanaflex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zanaflex APIs or Zanaflex finished pharmaceutical products to another nation, regulatory agencies frequently require a Zanaflex WC (written confirmation) as part of the regulatory process.
click here to find a list of Zanaflex 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 Zanaflex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zanaflex 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 Zanaflex 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 Zanaflex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zanaflex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zanaflex suppliers with NDC on PharmaCompass.
Zanaflex 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 Zanaflex 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 Zanaflex GMP manufacturer or Zanaflex GMP API supplier for your needs.
A Zanaflex CoA (Certificate of Analysis) is a formal document that attests to Zanaflex's compliance with Zanaflex specifications and serves as a tool for batch-level quality control.
Zanaflex CoA mostly includes findings from lab analyses of a specific batch. For each Zanaflex 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.
Zanaflex may be tested according to a variety of international standards, such as European Pharmacopoeia (Zanaflex EP), Zanaflex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zanaflex USP).
