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