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KDMF
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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
Faran Shimi Pharmaceutical
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APIs
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FDF DOSSIERS
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31 Oct 2017
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REF. STANDARDS & IMPURITIES
EDQM
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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 Bicillin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bicillin, including repackagers and relabelers. The FDA regulates Bicillin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bicillin 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 Bicillin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bicillin supplier is an individual or a company that provides Bicillin active pharmaceutical ingredient (API) or Bicillin finished formulations upon request. The Bicillin suppliers may include Bicillin API manufacturers, exporters, distributors and traders.
click here to find a list of Bicillin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bicillin DMF (Drug Master File) is a document detailing the whole manufacturing process of Bicillin active pharmaceutical ingredient (API) in detail. Different forms of Bicillin DMFs exist exist since differing nations have different regulations, such as Bicillin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bicillin DMF submitted to regulatory agencies in the US is known as a USDMF. Bicillin USDMF includes data on Bicillin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bicillin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bicillin 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 Bicillin Drug Master File in Japan (Bicillin JDMF) empowers Bicillin 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 Bicillin JDMF during the approval evaluation for pharmaceutical products. At the time of Bicillin 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 Bicillin suppliers with JDMF on PharmaCompass.
A Bicillin CEP of the European Pharmacopoeia monograph is often referred to as a Bicillin Certificate of Suitability (COS). The purpose of a Bicillin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bicillin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bicillin to their clients by showing that a Bicillin CEP has been issued for it. The manufacturer submits a Bicillin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bicillin CEP holder for the record. Additionally, the data presented in the Bicillin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bicillin DMF.
A Bicillin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bicillin 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 Bicillin 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 Bicillin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bicillin 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 Bicillin 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 Bicillin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bicillin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bicillin suppliers with NDC on PharmaCompass.
Bicillin 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 Bicillin 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 Bicillin GMP manufacturer or Bicillin GMP API supplier for your needs.
A Bicillin CoA (Certificate of Analysis) is a formal document that attests to Bicillin's compliance with Bicillin specifications and serves as a tool for batch-level quality control.
Bicillin CoA mostly includes findings from lab analyses of a specific batch. For each Bicillin 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.
Bicillin may be tested according to a variety of international standards, such as European Pharmacopoeia (Bicillin EP), Bicillin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bicillin USP).
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