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EU WC
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Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
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API SUPPLIERS
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USDMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13615
Submission : 1998-09-01
Status :
Type : II
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-13
DMF Number : 13378
Submission : 1998-09-01
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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- 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - 400 UNITS/GM;E...DOSAGE - OINTMENT;OPHTHALMIC - 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
USFDA APPLICATION NUMBER - 50417
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Tablet
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
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Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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, 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.
A MYTREX A manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MYTREX A, including repackagers and relabelers. The FDA regulates MYTREX A manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MYTREX A 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 MYTREX A manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A MYTREX A supplier is an individual or a company that provides MYTREX A active pharmaceutical ingredient (API) or MYTREX A finished formulations upon request. The MYTREX A suppliers may include MYTREX A API manufacturers, exporters, distributors and traders.
click here to find a list of MYTREX A suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A MYTREX A DMF (Drug Master File) is a document detailing the whole manufacturing process of MYTREX A active pharmaceutical ingredient (API) in detail. Different forms of MYTREX A DMFs exist exist since differing nations have different regulations, such as MYTREX A USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MYTREX A DMF submitted to regulatory agencies in the US is known as a USDMF. MYTREX A USDMF includes data on MYTREX A's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MYTREX A USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MYTREX A 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 MYTREX A Drug Master File in Japan (MYTREX A JDMF) empowers MYTREX A 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 MYTREX A JDMF during the approval evaluation for pharmaceutical products. At the time of MYTREX A 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 MYTREX A 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 MYTREX A Drug Master File in Korea (MYTREX A KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MYTREX A. The MFDS reviews the MYTREX A KDMF as part of the drug registration process and uses the information provided in the MYTREX A KDMF to evaluate the safety and efficacy of the drug.
After submitting a MYTREX A 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 MYTREX A API can apply through the Korea Drug Master File (KDMF).
click here to find a list of MYTREX A suppliers with KDMF on PharmaCompass.
A MYTREX A CEP of the European Pharmacopoeia monograph is often referred to as a MYTREX A Certificate of Suitability (COS). The purpose of a MYTREX A CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MYTREX A EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MYTREX A to their clients by showing that a MYTREX A CEP has been issued for it. The manufacturer submits a MYTREX A CEP (COS) as part of the market authorization procedure, and it takes on the role of a MYTREX A CEP holder for the record. Additionally, the data presented in the MYTREX A CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MYTREX A DMF.
A MYTREX A CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MYTREX A 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 MYTREX A 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 MYTREX A as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for MYTREX A 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 MYTREX A 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 MYTREX A and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MYTREX A NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of MYTREX A suppliers with NDC on PharmaCompass.
MYTREX A 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 MYTREX A GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right MYTREX A GMP manufacturer or MYTREX A GMP API supplier for your needs.
A MYTREX A CoA (Certificate of Analysis) is a formal document that attests to MYTREX A's compliance with MYTREX A specifications and serves as a tool for batch-level quality control.
MYTREX A CoA mostly includes findings from lab analyses of a specific batch. For each MYTREX A 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.
MYTREX A may be tested according to a variety of international standards, such as European Pharmacopoeia (MYTREX A EP), MYTREX A JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MYTREX A USP).
