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USDMF
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36319
Submission : 2021-11-29
Status :
Type : IV
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ABOUT THIS PAGE
A Glucose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glucose, including repackagers and relabelers. The FDA regulates Glucose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glucose 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 Glucose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glucose supplier is an individual or a company that provides Glucose active pharmaceutical ingredient (API) or Glucose finished formulations upon request. The Glucose suppliers may include Glucose API manufacturers, exporters, distributors and traders.
click here to find a list of Glucose suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glucose DMF (Drug Master File) is a document detailing the whole manufacturing process of Glucose active pharmaceutical ingredient (API) in detail. Different forms of Glucose DMFs exist exist since differing nations have different regulations, such as Glucose USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glucose DMF submitted to regulatory agencies in the US is known as a USDMF. Glucose USDMF includes data on Glucose's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glucose USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glucose 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 Glucose Drug Master File in Japan (Glucose JDMF) empowers Glucose 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 Glucose JDMF during the approval evaluation for pharmaceutical products. At the time of Glucose 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 Glucose 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 Glucose Drug Master File in Korea (Glucose KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Glucose. The MFDS reviews the Glucose KDMF as part of the drug registration process and uses the information provided in the Glucose KDMF to evaluate the safety and efficacy of the drug.
After submitting a Glucose 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 Glucose API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Glucose suppliers with KDMF on PharmaCompass.
A Glucose CEP of the European Pharmacopoeia monograph is often referred to as a Glucose Certificate of Suitability (COS). The purpose of a Glucose CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Glucose EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Glucose to their clients by showing that a Glucose CEP has been issued for it. The manufacturer submits a Glucose CEP (COS) as part of the market authorization procedure, and it takes on the role of a Glucose CEP holder for the record. Additionally, the data presented in the Glucose CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Glucose DMF.
A Glucose CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Glucose 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 Glucose 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 Glucose as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Glucose 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 Glucose 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 Glucose and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Glucose NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Glucose suppliers with NDC on PharmaCompass.
Glucose 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 Glucose 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 Glucose GMP manufacturer or Glucose GMP API supplier for your needs.
A Glucose CoA (Certificate of Analysis) is a formal document that attests to Glucose's compliance with Glucose specifications and serves as a tool for batch-level quality control.
Glucose CoA mostly includes findings from lab analyses of a specific batch. For each Glucose 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.
Glucose may be tested according to a variety of international standards, such as European Pharmacopoeia (Glucose EP), Glucose JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glucose USP).
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