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