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API SUPPLIERS
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USDMF
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-03
Pay. Date : 2014-10-14
DMF Number : 15525
Submission : 2001-07-04
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-23
Pay. Date : 2013-04-12
DMF Number : 15699
Submission : 2001-11-02
Status :
Type : II
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Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Tizanidine hydrochloride (for manufacturing purposes only)
Registration Number : 227MF10142
Registrant's Address : Na vlcinci 16/3 Klasterni Hradisko 779 00 Olomouc Czech Republic
Initial Date of Registration : 2015-05-20
Latest Date of Registration : 2022-06-15
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0035a
Address of the Firm : Chemical Technical Operations Unit-V, Plot No 116, Sri Venkateshwara, Jinnaram M...
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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**Federal ...DOSAGE - TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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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 Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tizanidine Hydrochloride, including repackagers and relabelers. The FDA regulates Tizanidine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tizanidine Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tizanidine Hydrochloride supplier is an individual or a company that provides Tizanidine Hydrochloride active pharmaceutical ingredient (API) or Tizanidine Hydrochloride finished formulations upon request. The Tizanidine Hydrochloride suppliers may include Tizanidine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Tizanidine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tizanidine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Tizanidine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Tizanidine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Tizanidine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tizanidine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Tizanidine Hydrochloride USDMF includes data on Tizanidine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tizanidine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tizanidine Hydrochloride 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 Hydrochloride Drug Master File in Japan (Tizanidine Hydrochloride JDMF) empowers Tizanidine Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Tizanidine Hydrochloride 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 Hydrochloride 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 Hydrochloride Drug Master File in Korea (Tizanidine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tizanidine Hydrochloride. The MFDS reviews the Tizanidine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Tizanidine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tizanidine Hydrochloride 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 Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tizanidine Hydrochloride suppliers with KDMF on PharmaCompass.
A Tizanidine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Tizanidine Hydrochloride Certificate of Suitability (COS). The purpose of a Tizanidine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tizanidine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tizanidine Hydrochloride to their clients by showing that a Tizanidine Hydrochloride CEP has been issued for it. The manufacturer submits a Tizanidine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tizanidine Hydrochloride CEP holder for the record. Additionally, the data presented in the Tizanidine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tizanidine Hydrochloride DMF.
A Tizanidine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tizanidine Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Tizanidine Hydrochloride written confirmation (Tizanidine Hydrochloride WC) is an official document issued by a regulatory agency to a Tizanidine Hydrochloride manufacturer, verifying that the manufacturing facility of a Tizanidine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tizanidine Hydrochloride APIs or Tizanidine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Tizanidine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Tizanidine Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tizanidine Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tizanidine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tizanidine Hydrochloride suppliers with NDC on PharmaCompass.
Tizanidine Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Tizanidine Hydrochloride GMP API supplier for your needs.
A Tizanidine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Tizanidine Hydrochloride's compliance with Tizanidine Hydrochloride specifications and serves as a tool for batch-level quality control.
Tizanidine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Tizanidine Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Tizanidine Hydrochloride EP), Tizanidine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tizanidine Hydrochloride USP).
