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400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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