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Neomycin Sulfate

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ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 11 USDMF, 5 CEP/COS, 2 JDMF, 1 KDMF, 22 NDC API, 10 VMF, 10 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

159 FDF Dossiers, 114 FDA Orange Book, 4 Europe, 7 Canada, 4 South Africa, 30 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM, 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- 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION/DROPS;OTIC - EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML, OINTMENT;OPHTHALMIC - EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 5 DKSH, 1 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 13 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 19 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 32 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 4 Finar, 10 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 35 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 11 Roquette, 17 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 3 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

53 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 43 Solubilizers, 39 Topical, 29 Parenteral, 26 Direct Compression, 24 Controlled & Modified Release, 21 Film Formers & Plasticizers, 21 Thickeners and Stabilizers, 19 Lubricants & Glidants, 18 Emulsifying Agents, 16 Granulation, 15 Co-Processed Excipients, 10 Surfactant & Foaming Agents, 9 Taste Masking, 6 API Stability Enhancers, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Disintegrants & Superdisintegrants, 2 Rheology Modifiers, 1 Soft Gelatin

DIGITAL CONTENT

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GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 5 Finished Drug Prices

MARKET PLACE

56 APIs, 4 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 2 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
26/09/2024	Sanofi	France	ROUSSELL UCLAF	13615	NEOMYCIN SULFATE	1998-09-01	Inactive	II	N/A
26/09/2024	Pfizer CentreOne	U.S.A	PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INC	13378	NEOMYCIN SULFATE USP	1998-09-01	Active	II	Complete	2013-02-26	2013-02-13

List of Drug Master Files (DMF) of Neomycin Sulfate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Neomycin Sulfate

Neomycin Sulfate

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

23 API Suppliers

11 USDMF

5 CEP/COS

2 JDMF

1 KDMF

22 NDC API

10 VMF

10 Listed Suppliers

$ API Reference Price

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

FINISHED DOSAGE FORMULATIONS

159 FDF Dossiers

114 FDA Orange Book

4 Europe

7 Canada

4 South Africa

30 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

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**

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**

SUSPENSION/DROPS;OTIC - EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML

OINTMENT;OPHTHALMIC - EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

6 SPI Pharma

2 Seqens

5 DKSH

1 Jai Radhe Sales

4 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

13 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 ACG Worldwide

19 Actylis

1 Aeon Procare

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

32 BASF

10 Corel Pharma Chem

3 DFE Pharma

4 Finar

10 Gangwal Chemicals

4 Ideal Cures Pvt Ltd

35 Kerry

3 Kima Chemical

6 Lonza Capsugel

15 Microlex e.U

2 Nanjing Bold Chemical

2 Nippon Fine Chemical

2 Nomisma Healthcare

2 Novo Excipients

1 Pharmatrans-Sanaq

4 Pluviaendo

1 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

11 Roquette

17 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

3 Sigachi Industries

2 The Dow Chemical Company

2 Ulanqab Kema New Material

1 Valens Pharmachem

2 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

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

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