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DRUG PRODUCT COMPOSITIONS0
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Data Compilation #PharmaFlow
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API SUPPLIERS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
CEP/COS 
JDMF
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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
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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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Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
Registration Number : 217MF10976
Registrant's Address : 235 East 42nd Street, New York, NY 10017
Initial Date of Registration : 2005-11-14
Latest Date of Registration : 2022-06-22
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
About the Company : Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates.
...
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API Imports and Exports
Drugs in Development
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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 - 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
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Coating Systems & Additives
Solubilizers
Topical
Parenteral
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Controlled & Modified Release
Film Formers & Plasticizers
Direct Compression
Lubricants & Glidants
Emulsifying Agents
Granulation
Co-Processed Excipients
Surfactant & Foaming Agents
Taste Masking
API Stability Enhancers
Chewable & Orodispersible Aids
Empty Capsules
Vegetarian Capsules
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Rheology Modifiers
Disintegrants & Superdisintegrants
Soft Gelatin
Digital Content
NEWS #PharmaBuzz
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US Medicaid Prescriptions
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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, 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 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, COA and API Price 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, COA and API Price 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, API price, 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).
