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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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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- 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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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 NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1, including repackagers and relabelers. The FDA regulates NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 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 NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 supplier is an individual or a company that provides NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 active pharmaceutical ingredient (API) or NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 finished formulations upon request. The NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 suppliers may include NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 API manufacturers, exporters, distributors and traders.
click here to find a list of NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 active pharmaceutical ingredient (API) in detail. Different forms of NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 DMFs exist exist since differing nations have different regulations, such as NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 DMF submitted to regulatory agencies in the US is known as a USDMF. NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 USDMF includes data on NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 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 NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 Drug Master File in Japan (NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 JDMF) empowers NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 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 NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 JDMF during the approval evaluation for pharmaceutical products. At the time of NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 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 NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 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 NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 Drug Master File in Korea (NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1. The MFDS reviews the NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 KDMF as part of the drug registration process and uses the information provided in the NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 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 NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 suppliers with KDMF on PharmaCompass.
A NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 CEP of the European Pharmacopoeia monograph is often referred to as a NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 Certificate of Suitability (COS). The purpose of a NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 to their clients by showing that a NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 CEP has been issued for it. The manufacturer submits a NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 CEP holder for the record. Additionally, the data presented in the NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 DMF.
A NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 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 NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 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 NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 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 NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 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 NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 suppliers with NDC on PharmaCompass.
NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 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 NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 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 NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 GMP manufacturer or NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 GMP API supplier for your needs.
A NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 CoA (Certificate of Analysis) is a formal document that attests to NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1's compliance with NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 specifications and serves as a tool for batch-level quality control.
NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 CoA mostly includes findings from lab analyses of a specific batch. For each NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 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.
NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 EP), NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (NEOMYCIN SULFATE; POLYMYXIN B SULFATE GRAMICIDIN-1 USP).
