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