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