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API SUPPLIERS
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USDMF
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DOSAGE - OINTMENT;TOPICAL - 0.1% **Federal Re...DOSAGE - OINTMENT;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19568
DOSAGE - CREAM;TOPICAL - 0.1% **Federal Regis...DOSAGE - CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20279
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Prednicarbate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prednicarbate, including repackagers and relabelers. The FDA regulates Prednicarbate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prednicarbate 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 Prednicarbate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prednicarbate supplier is an individual or a company that provides Prednicarbate active pharmaceutical ingredient (API) or Prednicarbate finished formulations upon request. The Prednicarbate suppliers may include Prednicarbate API manufacturers, exporters, distributors and traders.
click here to find a list of Prednicarbate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prednicarbate DMF (Drug Master File) is a document detailing the whole manufacturing process of Prednicarbate active pharmaceutical ingredient (API) in detail. Different forms of Prednicarbate DMFs exist exist since differing nations have different regulations, such as Prednicarbate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prednicarbate DMF submitted to regulatory agencies in the US is known as a USDMF. Prednicarbate USDMF includes data on Prednicarbate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prednicarbate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prednicarbate 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 Prednicarbate Drug Master File in Korea (Prednicarbate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prednicarbate. The MFDS reviews the Prednicarbate KDMF as part of the drug registration process and uses the information provided in the Prednicarbate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prednicarbate 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 Prednicarbate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Prednicarbate suppliers with KDMF on PharmaCompass.
A Prednicarbate CEP of the European Pharmacopoeia monograph is often referred to as a Prednicarbate Certificate of Suitability (COS). The purpose of a Prednicarbate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prednicarbate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prednicarbate to their clients by showing that a Prednicarbate CEP has been issued for it. The manufacturer submits a Prednicarbate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prednicarbate CEP holder for the record. Additionally, the data presented in the Prednicarbate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prednicarbate DMF.
A Prednicarbate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prednicarbate 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 Prednicarbate suppliers with CEP (COS) 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 Prednicarbate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prednicarbate 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 Prednicarbate 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 Prednicarbate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prednicarbate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prednicarbate suppliers with NDC on PharmaCompass.
Prednicarbate 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 Prednicarbate 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 Prednicarbate GMP manufacturer or Prednicarbate GMP API supplier for your needs.
A Prednicarbate CoA (Certificate of Analysis) is a formal document that attests to Prednicarbate's compliance with Prednicarbate specifications and serves as a tool for batch-level quality control.
Prednicarbate CoA mostly includes findings from lab analyses of a specific batch. For each Prednicarbate 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.
Prednicarbate may be tested according to a variety of international standards, such as European Pharmacopoeia (Prednicarbate EP), Prednicarbate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prednicarbate USP).
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