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