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PharmaCompass offers a list of Benzyl Penicillin 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 Benzyl Penicillin manufacturer or Benzyl Penicillin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benzyl Penicillin manufacturer or Benzyl Penicillin supplier.
PharmaCompass also assists you with knowing the Benzyl Penicillin API Price utilized in the formulation of products. Benzyl Penicillin API Price is not always fixed or binding as the Benzyl Penicillin Price is obtained through a variety of data sources. The Benzyl Penicillin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Benzyl Penicillin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzyl Penicillin, including repackagers and relabelers. The FDA regulates Benzyl Penicillin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzyl Penicillin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Benzyl Penicillin supplier is an individual or a company that provides Benzyl Penicillin active pharmaceutical ingredient (API) or Benzyl Penicillin finished formulations upon request. The Benzyl Penicillin suppliers may include Benzyl Penicillin API manufacturers, exporters, distributors and traders.
click here to find a list of Benzyl Penicillin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benzyl Penicillin DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzyl Penicillin active pharmaceutical ingredient (API) in detail. Different forms of Benzyl Penicillin DMFs exist exist since differing nations have different regulations, such as Benzyl Penicillin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benzyl Penicillin DMF submitted to regulatory agencies in the US is known as a USDMF. Benzyl Penicillin USDMF includes data on Benzyl Penicillin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzyl Penicillin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benzyl Penicillin 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 Benzyl Penicillin Drug Master File in Japan (Benzyl Penicillin JDMF) empowers Benzyl Penicillin 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 Benzyl Penicillin JDMF during the approval evaluation for pharmaceutical products. At the time of Benzyl Penicillin 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 Benzyl Penicillin suppliers with JDMF on PharmaCompass.
A Benzyl Penicillin written confirmation (Benzyl Penicillin WC) is an official document issued by a regulatory agency to a Benzyl Penicillin manufacturer, verifying that the manufacturing facility of a Benzyl Penicillin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Benzyl Penicillin APIs or Benzyl Penicillin finished pharmaceutical products to another nation, regulatory agencies frequently require a Benzyl Penicillin WC (written confirmation) as part of the regulatory process.
click here to find a list of Benzyl Penicillin suppliers with Written Confirmation (WC) 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 Benzyl Penicillin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Benzyl Penicillin 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 Benzyl Penicillin 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 Benzyl Penicillin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Benzyl Penicillin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Benzyl Penicillin suppliers with NDC on PharmaCompass.
Benzyl Penicillin 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 Benzyl Penicillin 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 Benzyl Penicillin GMP manufacturer or Benzyl Penicillin GMP API supplier for your needs.
A Benzyl Penicillin CoA (Certificate of Analysis) is a formal document that attests to Benzyl Penicillin's compliance with Benzyl Penicillin specifications and serves as a tool for batch-level quality control.
Benzyl Penicillin CoA mostly includes findings from lab analyses of a specific batch. For each Benzyl Penicillin 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.
Benzyl Penicillin may be tested according to a variety of international standards, such as European Pharmacopoeia (Benzyl Penicillin EP), Benzyl Penicillin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benzyl Penicillin USP).
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