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