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DRUG PRODUCT COMPOSITIONS0
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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.
Suanfarma, at the Core of a Better Life.
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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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...
Suanfarma, at the Core of a Better Life.
About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indu...
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
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FDF Dossiers
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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 - 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
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : CM90 is a directly compressible, granulated calcium carbonate with maltodextrin used for swallow tablets due to its high density and compressibility.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 490- 500, Tapped Density: 1.50
Ingredient(s) : Calcium Carbonate Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Softgels
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : Vitasmooth is a directly compressible calcium carbonate, preformulated with excipients used for the production of chewable or antacid meltaway tablets
Pharmacopoeia Ref : NA
Technical Specs : Tapped Density: 0.80, PSD D50: 153
Ingredient(s) : Calcium Carbonate Excipient
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seqens
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Capsule
Grade : Oral (Pharma Grade)
Application : Fillers, Diluents & Binders
Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.
Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP
Technical Specs : NA
Ingredient(s) : Polyvinylpyrrolidone
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Capsule
Grade : Oral (Pharma Grade)
Application : Fillers, Diluents & Binders
Excipient Details : KoVidone® K30 is used as a binder for tablets and capsules.
Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP
Technical Specs : NA
Ingredient(s) : Polyvinylpyrrolidone K30
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Gel
Grade : Oral
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Gel
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : DiCOM-DC S604 is used as a DC co-processed excipient with a combination of various polymers that act as fillers and binders in tablets and capsules.
Pharmacopoeia Ref : In-house
Technical Specs : Polyvinyl Pyrrolidone 97% & 93%
Ingredient(s) : Calcium Carbonate Excipient
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule
Grade : Oral
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule
Grade : Oral
Brand Name : Microlose™ M60 P60
Application : Fillers, Diluents & Binders
Excipient Details : Microlose M60 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.
Pharmacopoeia Ref : In-house
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Softgels
Grade : Oral
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Gel
Grade : Parenteral, Oral, Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : Lactose Monohydrate
Application : Parenteral
Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
Application : Solubilizers
Excipient Details : Poloxamer 188 is used as a solubilizer, emulsifier, stabilizer in parenteral, OSDs & topical formulations such as creams, gels & lotions.
Pharmacopoeia Ref : ChP/USP/EP
Technical Specs : Oxyethylene unit: 75%-85%, Oxypropylene unit: 25%-30%
Ingredient(s) : Poloxamer 188
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Gel
Grade : Oral, Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment
Grade : Parenteral, Oral, Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Gel
Grade : Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Emulsion
Grade : Oral, Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Softgels
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
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Parenteral
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Neomycin Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Neomycin Sulfate, including repackagers and relabelers. The FDA regulates Neomycin Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Neomycin 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 Neomycin Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Neomycin Sulfate supplier is an individual or a company that provides Neomycin Sulfate active pharmaceutical ingredient (API) or Neomycin Sulfate finished formulations upon request. The Neomycin Sulfate suppliers may include Neomycin Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Neomycin Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Neomycin Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Neomycin Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Neomycin Sulfate DMFs exist exist since differing nations have different regulations, such as Neomycin Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Neomycin Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Neomycin Sulfate USDMF includes data on Neomycin Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Neomycin Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Neomycin 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 Neomycin Sulfate Drug Master File in Japan (Neomycin Sulfate JDMF) empowers Neomycin 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 Neomycin Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Neomycin 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 Neomycin 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 Neomycin Sulfate Drug Master File in Korea (Neomycin Sulfate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Neomycin Sulfate. The MFDS reviews the Neomycin Sulfate KDMF as part of the drug registration process and uses the information provided in the Neomycin Sulfate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Neomycin 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 Neomycin Sulfate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Neomycin Sulfate suppliers with KDMF on PharmaCompass.
A Neomycin Sulfate CEP of the European Pharmacopoeia monograph is often referred to as a Neomycin Sulfate Certificate of Suitability (COS). The purpose of a Neomycin Sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Neomycin Sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Neomycin Sulfate to their clients by showing that a Neomycin Sulfate CEP has been issued for it. The manufacturer submits a Neomycin Sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Neomycin Sulfate CEP holder for the record. Additionally, the data presented in the Neomycin Sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Neomycin Sulfate DMF.
A Neomycin Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Neomycin 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 Neomycin 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 Neomycin Sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Neomycin 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 Neomycin 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 Neomycin Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Neomycin Sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Neomycin Sulfate suppliers with NDC on PharmaCompass.
Neomycin 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 Neomycin 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 Neomycin Sulfate GMP manufacturer or Neomycin Sulfate GMP API supplier for your needs.
A Neomycin Sulfate CoA (Certificate of Analysis) is a formal document that attests to Neomycin Sulfate's compliance with Neomycin Sulfate specifications and serves as a tool for batch-level quality control.
Neomycin Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Neomycin 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.
Neomycin Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Neomycin Sulfate EP), Neomycin Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Neomycin Sulfate USP).
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