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