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