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Polymyxin B Sulfate

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 13 USDMF, 6 CEP/COS, 2 JDMF, 1 EU WC, 2 KDMF, 20 NDC API, 20 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

FINISHED DOSAGE FORMULATIONS

145 FDF Dossiers, 95 FDA Orange Book, 7 Europe, 19 Canada, 8 South Africa, 16 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- 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, OINTMENT;OPHTHALMIC - EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM, SOLUTION/DROPS;OPHTHALMIC - 10,000 UNITS/ML;EQ 1MG BASE/ML

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 Seqens, 2 DKSH, 1 Jai Radhe Sales, 1 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 17 Actylis, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 24 BASF, 10 Corel Pharma Chem, 3 Finar, 9 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 19 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 4 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 5 Roquette, 17 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

44 Coating Systems & Additives, 36 Topical, 33 Solubilizers, 22 Parenteral, 21 Controlled & Modified Release, 19 Thickeners and Stabilizers, 17 Emulsifying Agents, 15 Film Formers & Plasticizers, 11 Co-Processed Excipients, 10 Surfactant & Foaming Agents, 9 Direct Compression, 7 Fillers, Diluents & Binders, 7 Granulation, 5 Lubricants & Glidants, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 3 Taste Masking, 2 Rheology Modifiers, 2 Coloring Agents, 1 Chewable & Orodispersible Aids, 1 Disintegrants & Superdisintegrants

DIGITAL CONTENT

12 NEWS #PharmaBuzz

12 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 5 Finished Drug Prices, 1 Annual Reports

MARKET PLACE

29 APIs, 7 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 1 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
28/10/2024	ALP Pharm	China	ALP PHARM BEIJING CO LTD	23997	POLYMYXIN B SULFATE USP	2010-07-02	Active	II	N/A
28/10/2024	BIOTIKA a.s.	Slovakia	BIOTIKA AS	23876	POLYMYXIN B SULFATE	2010-05-31	Active	II	Complete	2014-09-29	2013-12-11

Polymyxin B Sulfate

Polymyxin B Sulfate

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

31 API Suppliers

13 USDMF

6 CEP/COS

2 JDMF

1 EU WC

2 KDMF

20 NDC API

20 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

7 Drugs in Development

FINISHED DOSAGE FORMULATIONS

145 FDF Dossiers

95 FDA Orange Book

7 Europe

19 Canada

8 South Africa

16 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**

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

SOLUTION/DROPS;OPHTHALMIC - 10,000 UNITS/ML;EQ 1MG BASE/ML

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

2 Seqens

2 DKSH

1 Jai Radhe Sales

1 Gangwal Healthcare

8 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 ACG Worldwide

17 Actylis

2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

24 BASF

10 Corel Pharma Chem

3 Finar

9 Gangwal Chemicals

4 Ideal Cures Pvt Ltd

19 Kerry

3 Kima Chemical

6 Lonza Capsugel

4 Microlex e.U

2 Nanjing Bold Chemical

2 Nippon Fine Chemical

2 Nomisma Healthcare

1 Novo Excipients

1 Pluviaendo

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

5 Roquette

17 Seppic

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Sigachi Industries

2 The Dow Chemical Company

1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

44 Coating Systems & Additives

36 Topical

33 Solubilizers

22 Parenteral

21 Controlled & Modified Release

19 Thickeners and Stabilizers

17 Emulsifying Agents

15 Film Formers & Plasticizers

11 Co-Processed Excipients

10 Surfactant & Foaming Agents

9 Direct Compression

7 Fillers, Diluents & Binders

7 Granulation

5 Lubricants & Glidants

5 Empty Capsules

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