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API SUPPLIERS
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USDMF
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DOSAGE - INJECTABLE;INJECTION - 150,000 UNITS...DOSAGE - INJECTABLE;INJECTION - 150,000 UNITS/ML;150,000 UNITS/ML
USFDA APPLICATION NUMBER - 50138
DOSAGE - INJECTABLE;INJECTION - 300,000 UNITS...DOSAGE - INJECTABLE;INJECTION - 300,000 UNITS/ML;300,000 UNITS/ML
USFDA APPLICATION NUMBER - 50138
DOSAGE - INJECTABLE;INJECTION - 900,000 UNITS...DOSAGE - INJECTABLE;INJECTION - 900,000 UNITS/2ML;300,000 UNITS/2ML
USFDA APPLICATION NUMBER - 50138
DOSAGE - INJECTABLE;INJECTION - 300,000 UNITS...DOSAGE - INJECTABLE;INJECTION - 300,000 UNITS/ML
USFDA APPLICATION NUMBER - 50141
DOSAGE - INJECTABLE;INJECTION - 600,000 UNITS...DOSAGE - INJECTABLE;INJECTION - 600,000 UNITS/ML
USFDA APPLICATION NUMBER - 50141
Related Excipient Companies
Boai NKY Pharmaceuticals Ltd
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
52
PharmaCompass offers a list of Penicillin G Benzathine 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 Penicillin G Benzathine manufacturer or Penicillin G Benzathine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Penicillin G Benzathine manufacturer or Penicillin G Benzathine supplier.
PharmaCompass also assists you with knowing the Penicillin G Benzathine API Price utilized in the formulation of products. Penicillin G Benzathine API Price is not always fixed or binding as the Penicillin G Benzathine Price is obtained through a variety of data sources. The Penicillin G Benzathine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bencelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bencelin, including repackagers and relabelers. The FDA regulates Bencelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bencelin 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 Bencelin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bencelin supplier is an individual or a company that provides Bencelin active pharmaceutical ingredient (API) or Bencelin finished formulations upon request. The Bencelin suppliers may include Bencelin API manufacturers, exporters, distributors and traders.
click here to find a list of Bencelin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bencelin DMF (Drug Master File) is a document detailing the whole manufacturing process of Bencelin active pharmaceutical ingredient (API) in detail. Different forms of Bencelin DMFs exist exist since differing nations have different regulations, such as Bencelin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bencelin DMF submitted to regulatory agencies in the US is known as a USDMF. Bencelin USDMF includes data on Bencelin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bencelin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bencelin 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 Bencelin Drug Master File in Japan (Bencelin JDMF) empowers Bencelin 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 Bencelin JDMF during the approval evaluation for pharmaceutical products. At the time of Bencelin 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 Bencelin suppliers with JDMF on PharmaCompass.
A Bencelin CEP of the European Pharmacopoeia monograph is often referred to as a Bencelin Certificate of Suitability (COS). The purpose of a Bencelin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bencelin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bencelin to their clients by showing that a Bencelin CEP has been issued for it. The manufacturer submits a Bencelin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bencelin CEP holder for the record. Additionally, the data presented in the Bencelin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bencelin DMF.
A Bencelin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bencelin 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 Bencelin 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 Bencelin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bencelin 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 Bencelin 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 Bencelin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bencelin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bencelin suppliers with NDC on PharmaCompass.
Bencelin 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 Bencelin 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 Bencelin GMP manufacturer or Bencelin GMP API supplier for your needs.
A Bencelin CoA (Certificate of Analysis) is a formal document that attests to Bencelin's compliance with Bencelin specifications and serves as a tool for batch-level quality control.
Bencelin CoA mostly includes findings from lab analyses of a specific batch. For each Bencelin 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.
Bencelin may be tested according to a variety of international standards, such as European Pharmacopoeia (Bencelin EP), Bencelin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bencelin USP).
