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