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