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PharmaCompass offers a list of Glucose 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 Glucose manufacturer or Glucose supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Glucose manufacturer or Glucose supplier.
PharmaCompass also assists you with knowing the Glucose API Price utilized in the formulation of products. Glucose API Price is not always fixed or binding as the Glucose Price is obtained through a variety of data sources. The Glucose Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Glucosteril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glucosteril, including repackagers and relabelers. The FDA regulates Glucosteril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glucosteril 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 Glucosteril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glucosteril supplier is an individual or a company that provides Glucosteril active pharmaceutical ingredient (API) or Glucosteril finished formulations upon request. The Glucosteril suppliers may include Glucosteril API manufacturers, exporters, distributors and traders.
click here to find a list of Glucosteril suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glucosteril DMF (Drug Master File) is a document detailing the whole manufacturing process of Glucosteril active pharmaceutical ingredient (API) in detail. Different forms of Glucosteril DMFs exist exist since differing nations have different regulations, such as Glucosteril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glucosteril DMF submitted to regulatory agencies in the US is known as a USDMF. Glucosteril USDMF includes data on Glucosteril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glucosteril USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glucosteril 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 Glucosteril Drug Master File in Japan (Glucosteril JDMF) empowers Glucosteril 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 Glucosteril JDMF during the approval evaluation for pharmaceutical products. At the time of Glucosteril 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 Glucosteril 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 Glucosteril Drug Master File in Korea (Glucosteril KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Glucosteril. The MFDS reviews the Glucosteril KDMF as part of the drug registration process and uses the information provided in the Glucosteril KDMF to evaluate the safety and efficacy of the drug.
After submitting a Glucosteril 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 Glucosteril API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Glucosteril suppliers with KDMF on PharmaCompass.
A Glucosteril CEP of the European Pharmacopoeia monograph is often referred to as a Glucosteril Certificate of Suitability (COS). The purpose of a Glucosteril CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Glucosteril EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Glucosteril to their clients by showing that a Glucosteril CEP has been issued for it. The manufacturer submits a Glucosteril CEP (COS) as part of the market authorization procedure, and it takes on the role of a Glucosteril CEP holder for the record. Additionally, the data presented in the Glucosteril CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Glucosteril DMF.
A Glucosteril CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Glucosteril 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 Glucosteril 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 Glucosteril as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Glucosteril 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 Glucosteril 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 Glucosteril and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Glucosteril NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Glucosteril suppliers with NDC on PharmaCompass.
Glucosteril 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 Glucosteril 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 Glucosteril GMP manufacturer or Glucosteril GMP API supplier for your needs.
A Glucosteril CoA (Certificate of Analysis) is a formal document that attests to Glucosteril's compliance with Glucosteril specifications and serves as a tool for batch-level quality control.
Glucosteril CoA mostly includes findings from lab analyses of a specific batch. For each Glucosteril 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.
Glucosteril may be tested according to a variety of international standards, such as European Pharmacopoeia (Glucosteril EP), Glucosteril JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glucosteril USP).
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