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