Synopsis
0
EU WC
0
KDMF
0
VMF
0
Europe
0
Australia
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
USP
ABOUT THIS PAGE
A Benzylpenicillin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzylpenicillin Sodium, including repackagers and relabelers. The FDA regulates Benzylpenicillin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzylpenicillin Sodium 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 Benzylpenicillin Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benzylpenicillin Sodium supplier is an individual or a company that provides Benzylpenicillin Sodium active pharmaceutical ingredient (API) or Benzylpenicillin Sodium finished formulations upon request. The Benzylpenicillin Sodium suppliers may include Benzylpenicillin Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Benzylpenicillin Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benzylpenicillin Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzylpenicillin Sodium active pharmaceutical ingredient (API) in detail. Different forms of Benzylpenicillin Sodium DMFs exist exist since differing nations have different regulations, such as Benzylpenicillin Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benzylpenicillin Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Benzylpenicillin Sodium USDMF includes data on Benzylpenicillin Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzylpenicillin Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benzylpenicillin Sodium 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 Benzylpenicillin Sodium Drug Master File in Japan (Benzylpenicillin Sodium JDMF) empowers Benzylpenicillin Sodium 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 Benzylpenicillin Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Benzylpenicillin Sodium 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 Benzylpenicillin Sodium suppliers with JDMF on PharmaCompass.
A Benzylpenicillin Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Benzylpenicillin Sodium Certificate of Suitability (COS). The purpose of a Benzylpenicillin Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Benzylpenicillin Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Benzylpenicillin Sodium to their clients by showing that a Benzylpenicillin Sodium CEP has been issued for it. The manufacturer submits a Benzylpenicillin Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Benzylpenicillin Sodium CEP holder for the record. Additionally, the data presented in the Benzylpenicillin Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Benzylpenicillin Sodium DMF.
A Benzylpenicillin Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Benzylpenicillin Sodium 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 Benzylpenicillin Sodium 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 Benzylpenicillin Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Benzylpenicillin Sodium 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 Benzylpenicillin Sodium 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 Benzylpenicillin Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Benzylpenicillin Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Benzylpenicillin Sodium suppliers with NDC on PharmaCompass.
Benzylpenicillin Sodium 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 Benzylpenicillin Sodium 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 Benzylpenicillin Sodium GMP manufacturer or Benzylpenicillin Sodium GMP API supplier for your needs.
A Benzylpenicillin Sodium CoA (Certificate of Analysis) is a formal document that attests to Benzylpenicillin Sodium's compliance with Benzylpenicillin Sodium specifications and serves as a tool for batch-level quality control.
Benzylpenicillin Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Benzylpenicillin Sodium 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.
Benzylpenicillin Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Benzylpenicillin Sodium EP), Benzylpenicillin Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benzylpenicillin Sodium USP).
LOOKING FOR A SUPPLIER?
