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DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;E...DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50168
DOSAGE - OINTMENT;OPHTHALMIC - EQ 400 UNITS/G...DOSAGE - OINTMENT;OPHTHALMIC - EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM
USFDA APPLICATION NUMBER - 50417
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ABOUT THIS PAGE
10
PharmaCompass offers a list of Bacitracin Zinc 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 Bacitracin Zinc manufacturer or Bacitracin Zinc supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bacitracin Zinc manufacturer or Bacitracin Zinc supplier.
PharmaCompass also assists you with knowing the Bacitracin Zinc API Price utilized in the formulation of products. Bacitracin Zinc API Price is not always fixed or binding as the Bacitracin Zinc Price is obtained through a variety of data sources. The Bacitracin Zinc Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bacitracin Zinc manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bacitracin Zinc, including repackagers and relabelers. The FDA regulates Bacitracin Zinc manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bacitracin Zinc 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 Bacitracin Zinc manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bacitracin Zinc supplier is an individual or a company that provides Bacitracin Zinc active pharmaceutical ingredient (API) or Bacitracin Zinc finished formulations upon request. The Bacitracin Zinc suppliers may include Bacitracin Zinc API manufacturers, exporters, distributors and traders.
click here to find a list of Bacitracin Zinc suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bacitracin Zinc DMF (Drug Master File) is a document detailing the whole manufacturing process of Bacitracin Zinc active pharmaceutical ingredient (API) in detail. Different forms of Bacitracin Zinc DMFs exist exist since differing nations have different regulations, such as Bacitracin Zinc USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bacitracin Zinc DMF submitted to regulatory agencies in the US is known as a USDMF. Bacitracin Zinc USDMF includes data on Bacitracin Zinc's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bacitracin Zinc USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bacitracin Zinc 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 Bacitracin Zinc Drug Master File in Japan (Bacitracin Zinc JDMF) empowers Bacitracin Zinc 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 Bacitracin Zinc JDMF during the approval evaluation for pharmaceutical products. At the time of Bacitracin Zinc 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 Bacitracin Zinc suppliers with JDMF on PharmaCompass.
A Bacitracin Zinc CEP of the European Pharmacopoeia monograph is often referred to as a Bacitracin Zinc Certificate of Suitability (COS). The purpose of a Bacitracin Zinc CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bacitracin Zinc EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bacitracin Zinc to their clients by showing that a Bacitracin Zinc CEP has been issued for it. The manufacturer submits a Bacitracin Zinc CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bacitracin Zinc CEP holder for the record. Additionally, the data presented in the Bacitracin Zinc CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bacitracin Zinc DMF.
A Bacitracin Zinc CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bacitracin Zinc 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 Bacitracin Zinc 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 Bacitracin Zinc as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bacitracin Zinc 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 Bacitracin Zinc 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 Bacitracin Zinc and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bacitracin Zinc NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bacitracin Zinc suppliers with NDC on PharmaCompass.
Bacitracin Zinc 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 Bacitracin Zinc 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 Bacitracin Zinc GMP manufacturer or Bacitracin Zinc GMP API supplier for your needs.
A Bacitracin Zinc CoA (Certificate of Analysis) is a formal document that attests to Bacitracin Zinc's compliance with Bacitracin Zinc specifications and serves as a tool for batch-level quality control.
Bacitracin Zinc CoA mostly includes findings from lab analyses of a specific batch. For each Bacitracin Zinc 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.
Bacitracin Zinc may be tested according to a variety of international standards, such as European Pharmacopoeia (Bacitracin Zinc EP), Bacitracin Zinc JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bacitracin Zinc USP).
