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Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Gramicidin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gramicidin, including repackagers and relabelers. The FDA regulates Gramicidin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gramicidin 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 Gramicidin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gramicidin supplier is an individual or a company that provides Gramicidin active pharmaceutical ingredient (API) or Gramicidin finished formulations upon request. The Gramicidin suppliers may include Gramicidin API manufacturers, exporters, distributors and traders.
click here to find a list of Gramicidin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gramicidin DMF (Drug Master File) is a document detailing the whole manufacturing process of Gramicidin active pharmaceutical ingredient (API) in detail. Different forms of Gramicidin DMFs exist exist since differing nations have different regulations, such as Gramicidin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gramicidin DMF submitted to regulatory agencies in the US is known as a USDMF. Gramicidin USDMF includes data on Gramicidin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gramicidin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gramicidin 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 Gramicidin Drug Master File in Japan (Gramicidin JDMF) empowers Gramicidin 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 Gramicidin JDMF during the approval evaluation for pharmaceutical products. At the time of Gramicidin 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 Gramicidin suppliers with JDMF on PharmaCompass.
A Gramicidin CEP of the European Pharmacopoeia monograph is often referred to as a Gramicidin Certificate of Suitability (COS). The purpose of a Gramicidin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gramicidin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gramicidin to their clients by showing that a Gramicidin CEP has been issued for it. The manufacturer submits a Gramicidin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gramicidin CEP holder for the record. Additionally, the data presented in the Gramicidin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gramicidin DMF.
A Gramicidin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gramicidin 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 Gramicidin 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 Gramicidin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gramicidin 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 Gramicidin 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 Gramicidin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gramicidin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gramicidin suppliers with NDC on PharmaCompass.
Gramicidin 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 Gramicidin 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 Gramicidin GMP manufacturer or Gramicidin GMP API supplier for your needs.
A Gramicidin CoA (Certificate of Analysis) is a formal document that attests to Gramicidin's compliance with Gramicidin specifications and serves as a tool for batch-level quality control.
Gramicidin CoA mostly includes findings from lab analyses of a specific batch. For each Gramicidin 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.
Gramicidin may be tested according to a variety of international standards, such as European Pharmacopoeia (Gramicidin EP), Gramicidin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gramicidin USP).
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