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PharmaCompass offers a list of Terbinafine Hydrochloride 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 Terbinafine Hydrochloride manufacturer or Terbinafine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Terbinafine Hydrochloride manufacturer or Terbinafine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Terbinafine Hydrochloride API Price utilized in the formulation of products. Terbinafine Hydrochloride API Price is not always fixed or binding as the Terbinafine Hydrochloride Price is obtained through a variety of data sources. The Terbinafine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 012C11ZU6G manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 012C11ZU6G, including repackagers and relabelers. The FDA regulates 012C11ZU6G manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 012C11ZU6G 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 012C11ZU6G manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 012C11ZU6G supplier is an individual or a company that provides 012C11ZU6G active pharmaceutical ingredient (API) or 012C11ZU6G finished formulations upon request. The 012C11ZU6G suppliers may include 012C11ZU6G API manufacturers, exporters, distributors and traders.
click here to find a list of 012C11ZU6G suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 012C11ZU6G DMF (Drug Master File) is a document detailing the whole manufacturing process of 012C11ZU6G active pharmaceutical ingredient (API) in detail. Different forms of 012C11ZU6G DMFs exist exist since differing nations have different regulations, such as 012C11ZU6G USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 012C11ZU6G DMF submitted to regulatory agencies in the US is known as a USDMF. 012C11ZU6G USDMF includes data on 012C11ZU6G's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 012C11ZU6G USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 012C11ZU6G Drug Master File in Japan (012C11ZU6G JDMF) empowers 012C11ZU6G 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 012C11ZU6G JDMF during the approval evaluation for pharmaceutical products. At the time of 012C11ZU6G 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 012C11ZU6G 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 012C11ZU6G Drug Master File in Korea (012C11ZU6G KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 012C11ZU6G. The MFDS reviews the 012C11ZU6G KDMF as part of the drug registration process and uses the information provided in the 012C11ZU6G KDMF to evaluate the safety and efficacy of the drug.
After submitting a 012C11ZU6G 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 012C11ZU6G API can apply through the Korea Drug Master File (KDMF).
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A 012C11ZU6G CEP of the European Pharmacopoeia monograph is often referred to as a 012C11ZU6G Certificate of Suitability (COS). The purpose of a 012C11ZU6G CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 012C11ZU6G EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 012C11ZU6G to their clients by showing that a 012C11ZU6G CEP has been issued for it. The manufacturer submits a 012C11ZU6G CEP (COS) as part of the market authorization procedure, and it takes on the role of a 012C11ZU6G CEP holder for the record. Additionally, the data presented in the 012C11ZU6G CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 012C11ZU6G DMF.
A 012C11ZU6G CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 012C11ZU6G CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A 012C11ZU6G written confirmation (012C11ZU6G WC) is an official document issued by a regulatory agency to a 012C11ZU6G manufacturer, verifying that the manufacturing facility of a 012C11ZU6G active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 012C11ZU6G APIs or 012C11ZU6G finished pharmaceutical products to another nation, regulatory agencies frequently require a 012C11ZU6G WC (written confirmation) as part of the regulatory process.
click here to find a list of 012C11ZU6G 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 012C11ZU6G as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 012C11ZU6G 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 012C11ZU6G 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 012C11ZU6G and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 012C11ZU6G NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 012C11ZU6G suppliers with NDC on PharmaCompass.
012C11ZU6G 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 012C11ZU6G 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 012C11ZU6G GMP manufacturer or 012C11ZU6G GMP API supplier for your needs.
A 012C11ZU6G CoA (Certificate of Analysis) is a formal document that attests to 012C11ZU6G's compliance with 012C11ZU6G specifications and serves as a tool for batch-level quality control.
012C11ZU6G CoA mostly includes findings from lab analyses of a specific batch. For each 012C11ZU6G 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.
012C11ZU6G may be tested according to a variety of international standards, such as European Pharmacopoeia (012C11ZU6G EP), 012C11ZU6G JP (Japanese Pharmacopeia) and the US Pharmacopoeia (012C11ZU6G USP).
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