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API SUPPLIERS
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ABOUT THIS PAGE
A Pipamperone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pipamperone, including repackagers and relabelers. The FDA regulates Pipamperone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pipamperone 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 Pipamperone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pipamperone supplier is an individual or a company that provides Pipamperone active pharmaceutical ingredient (API) or Pipamperone finished formulations upon request. The Pipamperone suppliers may include Pipamperone API manufacturers, exporters, distributors and traders.
click here to find a list of Pipamperone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pipamperone DMF (Drug Master File) is a document detailing the whole manufacturing process of Pipamperone active pharmaceutical ingredient (API) in detail. Different forms of Pipamperone DMFs exist exist since differing nations have different regulations, such as Pipamperone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pipamperone DMF submitted to regulatory agencies in the US is known as a USDMF. Pipamperone USDMF includes data on Pipamperone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pipamperone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pipamperone 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 Pipamperone Drug Master File in Japan (Pipamperone JDMF) empowers Pipamperone 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 Pipamperone JDMF during the approval evaluation for pharmaceutical products. At the time of Pipamperone 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 Pipamperone suppliers with JDMF 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 Pipamperone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pipamperone 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 Pipamperone 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 Pipamperone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pipamperone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pipamperone suppliers with NDC on PharmaCompass.
Pipamperone 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 Pipamperone 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 Pipamperone GMP manufacturer or Pipamperone GMP API supplier for your needs.
A Pipamperone CoA (Certificate of Analysis) is a formal document that attests to Pipamperone's compliance with Pipamperone specifications and serves as a tool for batch-level quality control.
Pipamperone CoA mostly includes findings from lab analyses of a specific batch. For each Pipamperone 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.
Pipamperone may be tested according to a variety of international standards, such as European Pharmacopoeia (Pipamperone EP), Pipamperone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pipamperone USP).
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