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SPI Pharma
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ledipasvir 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 Ledipasvir manufacturer or Ledipasvir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ledipasvir manufacturer or Ledipasvir supplier.
PharmaCompass also assists you with knowing the Ledipasvir API Price utilized in the formulation of products. Ledipasvir API Price is not always fixed or binding as the Ledipasvir Price is obtained through a variety of data sources. The Ledipasvir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 013TE6E4WV manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 013TE6E4WV, including repackagers and relabelers. The FDA regulates 013TE6E4WV manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 013TE6E4WV 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 013TE6E4WV manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 013TE6E4WV supplier is an individual or a company that provides 013TE6E4WV active pharmaceutical ingredient (API) or 013TE6E4WV finished formulations upon request. The 013TE6E4WV suppliers may include 013TE6E4WV API manufacturers, exporters, distributors and traders.
click here to find a list of 013TE6E4WV suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 013TE6E4WV DMF (Drug Master File) is a document detailing the whole manufacturing process of 013TE6E4WV active pharmaceutical ingredient (API) in detail. Different forms of 013TE6E4WV DMFs exist exist since differing nations have different regulations, such as 013TE6E4WV USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 013TE6E4WV DMF submitted to regulatory agencies in the US is known as a USDMF. 013TE6E4WV USDMF includes data on 013TE6E4WV's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 013TE6E4WV USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 013TE6E4WV 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 013TE6E4WV Drug Master File in Korea (013TE6E4WV KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 013TE6E4WV. The MFDS reviews the 013TE6E4WV KDMF as part of the drug registration process and uses the information provided in the 013TE6E4WV KDMF to evaluate the safety and efficacy of the drug.
After submitting a 013TE6E4WV 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 013TE6E4WV API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 013TE6E4WV suppliers with KDMF on PharmaCompass.
A 013TE6E4WV written confirmation (013TE6E4WV WC) is an official document issued by a regulatory agency to a 013TE6E4WV manufacturer, verifying that the manufacturing facility of a 013TE6E4WV active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 013TE6E4WV APIs or 013TE6E4WV finished pharmaceutical products to another nation, regulatory agencies frequently require a 013TE6E4WV WC (written confirmation) as part of the regulatory process.
click here to find a list of 013TE6E4WV 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 013TE6E4WV as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 013TE6E4WV 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 013TE6E4WV 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 013TE6E4WV and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 013TE6E4WV NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 013TE6E4WV suppliers with NDC on PharmaCompass.
013TE6E4WV 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 013TE6E4WV 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 013TE6E4WV GMP manufacturer or 013TE6E4WV GMP API supplier for your needs.
A 013TE6E4WV CoA (Certificate of Analysis) is a formal document that attests to 013TE6E4WV's compliance with 013TE6E4WV specifications and serves as a tool for batch-level quality control.
013TE6E4WV CoA mostly includes findings from lab analyses of a specific batch. For each 013TE6E4WV 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.
013TE6E4WV may be tested according to a variety of international standards, such as European Pharmacopoeia (013TE6E4WV EP), 013TE6E4WV JP (Japanese Pharmacopeia) and the US Pharmacopoeia (013TE6E4WV USP).
