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API SUPPLIERS
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USDMF
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Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
About the Company : Farmak, A.S. is a privately held chemical and pharmaceutical company based in the Czech Republic. It specializes in researching, developing and producing active pharmaceutical ingr...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
About the Company : JPN Pharma is a premier pharmaceutical company in India, specializing in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug intermediates. Headq...
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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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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 Tizanidine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tizanidine HCl, including repackagers and relabelers. The FDA regulates Tizanidine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tizanidine HCl 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 Tizanidine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tizanidine HCl supplier is an individual or a company that provides Tizanidine HCl active pharmaceutical ingredient (API) or Tizanidine HCl finished formulations upon request. The Tizanidine HCl suppliers may include Tizanidine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Tizanidine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tizanidine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Tizanidine HCl active pharmaceutical ingredient (API) in detail. Different forms of Tizanidine HCl DMFs exist exist since differing nations have different regulations, such as Tizanidine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tizanidine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Tizanidine HCl USDMF includes data on Tizanidine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tizanidine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tizanidine HCl 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 Tizanidine HCl Drug Master File in Japan (Tizanidine HCl JDMF) empowers Tizanidine HCl 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 Tizanidine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Tizanidine HCl 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 Tizanidine HCl 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 Tizanidine HCl Drug Master File in Korea (Tizanidine HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tizanidine HCl. The MFDS reviews the Tizanidine HCl KDMF as part of the drug registration process and uses the information provided in the Tizanidine HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tizanidine HCl 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 Tizanidine HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tizanidine HCl suppliers with KDMF on PharmaCompass.
A Tizanidine HCl CEP of the European Pharmacopoeia monograph is often referred to as a Tizanidine HCl Certificate of Suitability (COS). The purpose of a Tizanidine HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tizanidine HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tizanidine HCl to their clients by showing that a Tizanidine HCl CEP has been issued for it. The manufacturer submits a Tizanidine HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tizanidine HCl CEP holder for the record. Additionally, the data presented in the Tizanidine HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tizanidine HCl DMF.
A Tizanidine HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tizanidine HCl 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 Tizanidine HCl suppliers with CEP (COS) on PharmaCompass.
A Tizanidine HCl written confirmation (Tizanidine HCl WC) is an official document issued by a regulatory agency to a Tizanidine HCl manufacturer, verifying that the manufacturing facility of a Tizanidine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tizanidine HCl APIs or Tizanidine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Tizanidine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Tizanidine HCl 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 Tizanidine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tizanidine HCl 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 Tizanidine HCl 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 Tizanidine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tizanidine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tizanidine HCl suppliers with NDC on PharmaCompass.
Tizanidine HCl 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 Tizanidine HCl 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 Tizanidine HCl GMP manufacturer or Tizanidine HCl GMP API supplier for your needs.
A Tizanidine HCl CoA (Certificate of Analysis) is a formal document that attests to Tizanidine HCl's compliance with Tizanidine HCl specifications and serves as a tool for batch-level quality control.
Tizanidine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Tizanidine HCl 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.
Tizanidine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Tizanidine HCl EP), Tizanidine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tizanidine HCl USP).
