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Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
Neomycin Sulfate, Micronised And Non-micronised
Certificate Number : R1-CEP 1999-184 - Rev 03
Status : Valid
Issue Date : 2020-04-21
Type : Chemical
Substance Number : 197
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DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG ...DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
USFDA APPLICATION NUMBER - 50065
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- 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/G...DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50218
DOSAGE - SUSPENSION/DROPS;OTIC - EQ 3MG BASE/...DOSAGE - SUSPENSION/DROPS;OTIC - EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML
USFDA APPLICATION NUMBER - 50356
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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PharmaCompass offers a list of Neomycin Sulfate 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 Neomycin Sulfate manufacturer or Neomycin Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Neomycin Sulfate manufacturer or Neomycin Sulfate supplier.
PharmaCompass also assists you with knowing the Neomycin Sulfate API Price utilized in the formulation of products. Neomycin Sulfate API Price is not always fixed or binding as the Neomycin Sulfate Price is obtained through a variety of data sources. The Neomycin Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Framycin Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Framycin Sulfate, including repackagers and relabelers. The FDA regulates Framycin Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Framycin Sulfate 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 Framycin Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Framycin Sulfate supplier is an individual or a company that provides Framycin Sulfate active pharmaceutical ingredient (API) or Framycin Sulfate finished formulations upon request. The Framycin Sulfate suppliers may include Framycin Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Framycin Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Framycin Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Framycin Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Framycin Sulfate DMFs exist exist since differing nations have different regulations, such as Framycin Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Framycin Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Framycin Sulfate USDMF includes data on Framycin Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Framycin Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Framycin Sulfate 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 Framycin Sulfate Drug Master File in Japan (Framycin Sulfate JDMF) empowers Framycin Sulfate 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 Framycin Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Framycin Sulfate 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 Framycin Sulfate suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Framycin Sulfate Drug Master File in Korea (Framycin Sulfate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Framycin Sulfate. The MFDS reviews the Framycin Sulfate KDMF as part of the drug registration process and uses the information provided in the Framycin Sulfate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Framycin Sulfate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Framycin Sulfate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Framycin Sulfate suppliers with KDMF on PharmaCompass.
A Framycin Sulfate CEP of the European Pharmacopoeia monograph is often referred to as a Framycin Sulfate Certificate of Suitability (COS). The purpose of a Framycin Sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Framycin Sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Framycin Sulfate to their clients by showing that a Framycin Sulfate CEP has been issued for it. The manufacturer submits a Framycin Sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Framycin Sulfate CEP holder for the record. Additionally, the data presented in the Framycin Sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Framycin Sulfate DMF.
A Framycin Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Framycin Sulfate 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 Framycin Sulfate 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 Framycin Sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Framycin Sulfate 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 Framycin Sulfate 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 Framycin Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Framycin Sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Framycin Sulfate suppliers with NDC on PharmaCompass.
Framycin Sulfate 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 Framycin Sulfate 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 Framycin Sulfate GMP manufacturer or Framycin Sulfate GMP API supplier for your needs.
A Framycin Sulfate CoA (Certificate of Analysis) is a formal document that attests to Framycin Sulfate's compliance with Framycin Sulfate specifications and serves as a tool for batch-level quality control.
Framycin Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Framycin Sulfate 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.
Framycin Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Framycin Sulfate EP), Framycin Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Framycin Sulfate USP).
