Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 13 USDMF, 6 CEP/COS, 2 JDMF, 1 EU WC, 2 KDMF, 20 NDC API, 21 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

FINISHED DOSAGE FORMULATIONS

144 FDF Dossiers, 95 FDA Orange Book, 7 Europe, 19 Canada, 7 South Africa, 16 Listed Dossiers

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400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, OINTMENT;OPHTHALMIC - EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM, SOLUTION/DROPS;OPHTHALMIC - 10,000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

drugProductComposition
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- 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 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 Granulation, 7 Fillers, Diluents & Binders, 5 API Stability Enhancers, 5 Lubricants & Glidants, 5 Empty Capsules, 4 Vegetarian Capsules, 3 Taste Masking, 2 Coloring Agents, 2 Rheology Modifiers, 1 Chewable & Orodispersible Aids, 1 Disintegrants & Superdisintegrants

DIGITAL CONTENT

12 NEWS #PharmaBuzz

media
12 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

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

MARKET PLACE

30 APIs, 7 FDF Dossiers

marketPlace
30 APIs
7 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM , 1 USP , 1 Others

otherSolutions
1 EDQM
1 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 4,753

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

144

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

7DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

51,845

Annual Reports (USD Million)

Finished Drug Prices

154 RELATED EXCIPIENT COMPANIES

279EXCIPIENTS BY APPLICATIONS

Chemistry

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Click the button for full data set

Also known as: Polymyxin b, sulfate (salt), 1405-20-5, Polymixin b sulphate, Ks-1428, Pmb, Akos025392172

Molecular Formula

C₅₆H₁₀₀N₁₆O₁₇S

Molecular Weight

1301.6 g/mol

InChI Key

HFMDLUQUEXNBOP-OLYKAHIFSA-N

1 2D Structure

Polymyxin B Sulfate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N-[(2S)-4-amino-1-[[(2S,3R)-1-[[(2S)-4-amino-1-oxo-1-[[(3S,6S,9S,12S,15R,18R,21S)-6,9,18-tris(2-aminoethyl)-15-benzyl-3-[(1R)-1-hydroxyethyl]-12-(2-methylpropyl)-2,5,8,11,14,17,20-heptaoxo-1,4,7,10,13,16,19-heptazacyclotricos-21-yl]amino]butan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1-oxobutan-2-yl]-6-methyloctanamide;sulfuric acid

2.1.2 InChI

InChI=1S/C56H98N16O13.H2O4S/c1-7-32(4)13-11-12-16-44(75)63-36(17-23-57)51(80)72-46(34(6)74)56(85)68-39(20-26-60)48(77)67-41-22-28-62-55(84)45(33(5)73)71-52(81)40(21-27-61)65-47(76)37(18-24-58)66-53(82)42(29-31(2)3)69-54(83)43(30-35-14-9-8-10-15-35)70-49(78)38(19-25-59)64-50(41)79;1-5(2,3)4/h8-10,14-15,31-34,36-43,45-46,73-74H,7,11-13,16-30,57-61H2,1-6H3,(H,62,84)(H,63,75)(H,64,79)(H,65,76)(H,66,82)(H,67,77)(H,68,85)(H,69,83)(H,70,78)(H,71,81)(H,72,80);(H2,1,2,3,4)/t32?,33-,34-,36+,37+,38-,39+,40+,41+,42+,43-,45+,46+;/m1./s1

2.1.3 InChI Key

HFMDLUQUEXNBOP-OLYKAHIFSA-N

2.1.4 Canonical SMILES

CCC(C)CCCCC(=O)NC(CCN)C(=O)NC(C(C)O)C(=O)NC(CCN)C(=O)NC1CCNC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC1=O)CCN)CC2=CC=CC=C2)CC(C)C)CCN)CCN)C(C)O.OS(=O)(=O)O

2.1.5 Isomeric SMILES

CCC(C)CCCCC(=O)N[C@@H](CCN)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCN)C(=O)N[C@H]1CCNC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@H](NC(=O)[C@H](NC1=O)CCN)CC2=CC=CC=C2)CC(C)C)CCN)CCN)[C@@H](C)O.OS(=O)(=O)O

2.2 Synonyms

2.2.1 Depositor-Supplied Synonyms

1. Polymyxin B, Sulfate (salt)

2. 1405-20-5

3. Polymixin B Sulphate

4. Ks-1428

5. Pmb

6. Akos025392172

7. Polymyxin B Sulfate, Bacillus Polymyxa

8. M02428

9. Polymyxin B Sulfate (1404-26-8 Free Base)

10. 405p205

2.3 Create Date

2010-12-22

3 Chemical and Physical Properties

Molecular Formula	C₅₆H₁₀₀N₁₆O₁₇S
Molecular Weight	1301.6 g/mol
Hydrogen Bond Donor Count	20
Hydrogen Bond Acceptor Count	22
Rotatable Bond Count	29
Exact Mass	1300.71730696 g/mol
Monoisotopic Mass	1300.71730696 g/mol
Topological Polar Surface Area	574 Å²
Heavy Atom Count	90
Formal Charge	0
Complexity	2240
Isotope Atom Count	0
Defined Atom Stereocenter Count	12
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Polymyxin b sulfate
Drug Label	Polymyxin B for Injection, USP is one of a group of basic polypeptide antibiotics derived from B polymyxa (B aerosporous). Polymyxin B sulfate is the sulfate salt of Polymyxins B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmow...
Active Ingredient	Polymyxin b sulfate
Dosage Form	Injectable
Route	Injection
Strength	eq 500,000 u base/vial
Market Status	Prescription
Company	X Gen Pharms; Xellia Pharms Aps; Fresenius Kabi Usa; Eurohlth Intl

2 of 2
Drug Name	Polymyxin b sulfate
Drug Label	Polymyxin B for Injection, USP is one of a group of basic polypeptide antibiotics derived from B polymyxa (B aerosporous). Polymyxin B sulfate is the sulfate salt of Polymyxins B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmow...
Active Ingredient	Polymyxin b sulfate
Dosage Form	Injectable
Route	Injection
Strength	eq 500,000 u base/vial
Market Status	Prescription
Company	X Gen Pharms; Xellia Pharms Aps; Fresenius Kabi Usa; Eurohlth Intl

API SUPPLIERS

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USDMF

01

Alp Pharm Beijing Co Ltd

China

Duphat

Not Confirmed

02

Biotika As

Slovakia

Duphat

Not Confirmed

03

Cultor Food Science Inc

U.S.A

Duphat

Not Confirmed

04

Hangzhou Zhongmei Huadong Pharmaceut...

China

Duphat

Not Confirmed

05

North China Pharmaceutical Huasheng ...

China

Duphat

Not Confirmed

06

Shandong Luxi Pharmaceutical Co Ltd

China

Duphat

Not Confirmed

07

World Jiangsu Industry Co Ltd

China

Duphat

Not Confirmed

08

Xellia Pharmaceuticals Aps

Denmark

Duphat

Not Confirmed

09

Xellia Pharmaceuticals Aps

Denmark

Duphat

Not Confirmed

10

Yancheng Youhua Pharmaceutical And C...

China

Duphat

Not Confirmed

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CEP/COS

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JDMF

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EU WC

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KDMF

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NDC API

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Listed Suppliers

01

ChemWerth Inc

U.S.A

VMX

Attending

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Polymyxin B Sulfate

About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...

Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs to regulated markets worldwide and has exclusive partnerships for new product development, compliance support and secure supply chain logistics. ChemWerth has access to over 500 APIs and more than 30 manufacturing facilities in the US, Europe, India and China. ChemWerth acts as a regulatory agent for over 25 FDA-approved facilities and sells more than 100 products. It has established its presence in 38 countries. In 2020, ChemWerth filed its 500th DMF with the FDA.

02

Transo-Pharm USA LLC

U.S.A

Duphat

Not Confirmed

TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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U.S.A

Virtual Booth

Digital Content

Polymyxin B Sulfate

About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...

Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout the entire API life cycle, from product development through sales. Transo-Pharm serves as a sourcing and regulatory marketing agent for API manufacturers. It aids clients in establishing DMFs and provides GMP consulting. With a dedicated regulatory department, a warehouse, proprietary IPs for API processes, and partnerships with laboratories, Transo-Pharm offers a wide range of services. It operates from its offices in Shanghai, Hong Kong, Singapore, and the US.

03

LGM Pharma

U.S.A

Duphat

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Polymyxin B Sulfate

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

04

Rochem International Inc

U.S.A

Suppliers Night Expo

Attending

Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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U.S.A

Virtual Booth

Digital Content

Polymyxin B Sulfate

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...

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-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.

05

Pharm-RX Chemical

U.S.A

Duphat

Not Confirmed

Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.

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U.S.A

Virtual Booth

Digital Content

Polymyxin B Sulfate

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...

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, nutritional supplement, and food industries. The company maintains an exceptionally selective approach to its suppliers, personally visiting manufacturers overseas to ensure the highest standards. The sustained growth of Pharm-Rx can be attributed to its steadfast commitment to three core values: quality ingredients, competitive pricing, and unparalleled customer service.

Corporate PDF

06

Shanghai Minbiotech

China

Duphat

Not Confirmed

Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

Contact Supplier

China

Virtual Booth

Digital Content

Polymyxin B Sulfate

About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...

Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry.

Corporate PDF

07

Fishfa Biogenics

India

Duphat

Not Confirmed

Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.

Contact Supplier

India

Virtual Booth

Digital Content

Polymyxin B

About the Company : Fishfa Biogenics, a division of Fishfa Rubbers Ltd., is a leading manufacturer and supplier of high-quality biological APIs. With GLP labs and WHO-GMP-certified facilities, Fishfa ...

Fishfa Biogenics, a division of Fishfa Rubbers Ltd., is a leading manufacturer and supplier of high-quality biological APIs. With GLP labs and WHO-GMP-certified facilities, Fishfa Biogenics specializes in fermentation production, process development and manufacturing. The company's manufacturing plant has a facility for microbial-based drug substance production and a quality-testing facility. Fishfa also provides technical, regulatory and IP support for its customers. The company exports its APIs like Mupirocin and Tacrolimus to countries in the Middle East, Europe, Asia, North and South America, Russia, New Zealand and the UK.

08

ALP Pharm

China

Duphat

Not Confirmed

09

Beijing Mesochem Technology

China

Duphat

Not Confirmed

10

Mac-Chem Products (India) Pvt.Ltd

India

Duphat

Not Confirmed

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API Reference Price

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HYDERABAD","customerAddress":""},{"dataSource":"API Import","activeIngredients":"POLYMYXIN B SULFATE","year":"2021","qtr":"Q1","strtotime":1615746600,"product":"POLYMYXIN B SULFATE USP","address":"304,?TOWN?CENTRE,?ANDHERI?KURLAROAD,?ANDHERI?(EAST),","city":"MUMBAI?\/?MAHARASHTRA","supplier":"CHEMEXCEL INTERNATIONAL ASIA ","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"MAC-CHEM PRODUCTS (INDIA) PVT.LTD","customerCountry":"INDIA","quantity":"12.50","actualQuantity":"12.5","unit":"KGS","unitRateFc":"3700","totalValueFC":"46947.9","currency":"USD","unitRateINR":"273430","date":"15-Mar-2021","totalValueINR":"3417875","totalValueInUsd":"46947.9","indian_port":"BOMBAY AIR","hs_no":"29419090","bill_no":"3137608","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"","customerAddress":"304,?TOWN?CENTRE,?ANDHERI?KURLAROAD,?ANDHERI?(EAST),"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1627497000,"product":"POLYMYXIN B SULFATE USP","address":"6-3-865\/1\/2, FLAT NO.201,GREENLAND APARTMENTS, AMEERPET,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"M\/S.CHEMEXCEL INTERNATIONAL (ASIA)","supplierCountry":"CHINA","foreign_port":"","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"32.00","actualQuantity":"32","unit":"KGS","unitRateFc":"4657.4","totalValueFC":"150783.1","currency":"USD","unitRateINR":"351168","date":"29-Jul-2021","totalValueINR":"11237374.72","totalValueInUsd":"150783.1","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"4854620","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"6-3-865\/1\/2, FLAT NO.201,GREENLAND 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KONGSDNF HK","customerAddress":"2NF FLOOR,BUILDING A,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703269800,"product":"POLYMYXIN B SULFATE( 50 BOU)","address":"2NF FLOOR,BUILDING A,","city":"ANDHERI[W],MUMBAI,","supplier":"CHEMEXEL INTERNAIONAL (ASIA) LIMIED","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"GUFIC BIOSCIENCES","customerCountry":"INDIA","quantity":"6.25","actualQuantity":"6.25","unit":"KGS","unitRateFc":"3920","totalValueFC":"24663.9","currency":"USD","unitRateINR":"328496","date":"23-Dec-2023","totalValueINR":"2053100","totalValueInUsd":"24663.9","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"9384780","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"RM 801-2 8\/F EASEY COMM BLDG 253-261 HENNESSY RD WANCHAI HONG KONGSDNF CN","customerAddress":"2NF FLOOR,BUILDING A,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707244200,"product":"POLYMYXIN B SULFATE( 50 BOU)","address":"2NF FLOOR,BUILDING A,","city":"ANDHERI[W],MUMBAI,","supplier":"CHEMEXCEL INTERNATIONAL ASIA ","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"GUFIC BIOSCIENCES","customerCountry":"INDIA","quantity":"6.25","actualQuantity":"6.25","unit":"KGS","unitRateFc":"3920","totalValueFC":"24788.3","currency":"USD","unitRateINR":"329084","date":"07-Feb-2024","totalValueINR":"2056775","totalValueInUsd":"24788.3","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"2025534","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"RM 801-2 8\/F EASEY COMMERCIAL BUILDING 253-261 HENNESSY ROAD WANCHAI RM 801-2 8\/F EASEY COMMERCIAL BUILDI CN","customerAddress":"2NF FLOOR,BUILDING A,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713119400,"product":"POLYMYXIN B SULFATE","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"CHEMEXCEL INTERNATIONAL ASIA ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"10.25","actualQuantity":"10.25","unit":"KGS","unitRateFc":"4400","totalValueFC":"45555.1","currency":"USD","unitRateINR":"371140","date":"15-Apr-2024","totalValueINR":"3804185","totalValueInUsd":"45555.1","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"3030329","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"N\/A","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715106600,"product":"POLYMYXIN B SULFATE USP","address":"194 ARVIND CHAMBERS 07 SAI SERVICE","city":"MUMBAI,MAHARASHTRA","supplier":"CHEMEXCEL INTERNATIONAL ASIA ","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"RIFA PHARMA","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"4945.1","totalValueFC":"5004.1","currency":"USD","unitRateINR":"417115","date":"08-May-2024","totalValueINR":"417114.97","totalValueInUsd":"5004.1","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"3388025","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"RM#801-2,8\/F., EASEY COMMERCIAL BUILDING , 253-261 HENNESSY ROAD, WANCHAI, HONG KONG Hong Kong","customerAddress":"194 ARVIND CHAMBERS 07 SAI SERVICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716748200,"product":"POLYMYXIN B SULFATE USP","address":"H NO.141, SILPA BRINDAVAN,","city":"KUKATPALLY, HYDERABAD, AP.","supplier":"CHEMEXCEL INTERNATIONAL ASIA ","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"ORBICULAR PHARMACEUTICAL TECHNOLOGIES ","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"4400","totalValueFC":"890.5","currency":"USD","unitRateINR":"371140","date":"27-May-2024","totalValueINR":"74228","totalValueInUsd":"890.5","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"3684016","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"801-2 EASEY COMMERCIAL BLDG. 253-261 HENNESSEY RD. WANCHAI, HONG KONGSDNF Hong Kong","customerAddress":"H NO.141, SILPA BRINDAVAN,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718735400,"product":"POLYMYXIN B SULFATE USP","address":"EOU R&D UNIT, M NO.1 A BLOCK,TEN","city":"TARAMANI CHENNAI,TAMIL NADU","supplier":"LUCKY STEP CORPORATION ","supplierCountry":"CHINA","foreign_port":"HONG KONG","customer":"AXXELENT PHARMA SCIENCE ","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"50","unit":"GMS","unitRateFc":"30","totalValueFC":"1515","currency":"USD","unitRateINR":"2529.4","date":"19-Jun-2024","totalValueINR":"126468.77","totalValueInUsd":"1515","indian_port":"Madras Air","hs_no":"29419090","bill_no":"4082475","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"FLAT\/RM 2108,21\/F,CC WU BUILDING,302-308 HENNESSY ROAD WAN CHAI,SDNF HONG KONG","customerAddress":"EOU R&D UNIT, M NO.1 A BLOCK,TEN"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720290600,"product":"POLYMYXIN B SULFATE USP","address":"H NO.141, SILPA BRINDAVAN,","city":"KUKATPALLY, HYDERABAD, AP.","supplier":"CHEMEXCEL INTERNATIONAL ASIA ","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"ORBICULAR PHARMACEUTICAL TECHNOLOGIES ","customerCountry":"INDIA","quantity":"0.80","actualQuantity":"0.8","unit":"KGS","unitRateFc":"4400","totalValueFC":"3556.2","currency":"USD","unitRateINR":"371580","date":"07-Jul-2024","totalValueINR":"297264","totalValueInUsd":"3556.2","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"4380662","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"Rm 801-2, 8\/F Easey Comm Bldg, 253-261 Hennessy Rd, Wanchai, Hong KongSDNF China","customerAddress":"H NO.141, SILPA BRINDAVAN,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720636200,"product":"POLYMYXIN B SULFATE USP ( NON -STERILE) [ QTY.: 78.99 BOU]","address":"UNIT NO.24 STEEL MADE INDL.ESTATE","city":"MUMBAI","supplier":"TRIO PHARMACEUTICAL INC","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"ENCUBE ETHICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"9.38","actualQuantity":"9.375","unit":"KGS","unitRateFc":"5603","totalValueFC":"53068.1","currency":"USD","unitRateINR":"473175.4","date":"11-Jul-2024","totalValueINR":"4436019.16","totalValueInUsd":"53068.1","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"4448634","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"ROOM 910,255 XIN JINQIAO ROADPUDONG, SHANGHAISDNF CN","customerAddress":"UNIT NO.24 STEEL MADE INDL.ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721413800,"product":"POLYMYXIN B SULFATE USP (QTY: 50BOU\/6.25KG AT USD 425.00 PERBOU USD3.4\/GRAM)","address":"2NF FLOOR,BUILDING A,","city":"ANDHERI[W],MUMBAI,","supplier":"CHEMEXCEL INTERNATIONAL (ASIA) LIMI","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"GUFIC BIOSCIENCES","customerCountry":"INDIA","quantity":"6.25","actualQuantity":"6.25","unit":"KGS","unitRateFc":"3400","totalValueFC":"21493.8","currency":"USD","unitRateINR":"287470","date":"20-Jul-2024","totalValueINR":"1796687.5","totalValueInUsd":"21493.8","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"4618108","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"TEDRM 801-2 8\/F EASEY COMM BLDG 253-261HENNESSY RD, WANCHAI,SDNF HONG KONG","customerAddress":"2NF FLOOR,BUILDING A,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726165800,"product":"POLYMYXIN B SULFATE","address":"NO 31, RACE COURSE ROAD,BANGALORE","city":"BENGALURU,KARNATAKA","supplier":"BIOTIKA A.S.","supplierCountry":"SLOVAKIA","foreign_port":"BRATISLAVA","customer":"MICRO LABS LIMITED","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"4400","totalValueFC":"2487.4","currency":"EUR","unitRateINR":"416900","date":"13-Sep-2024","totalValueINR":"208450","totalValueInUsd":"2487.4","indian_port":"Madras Air","hs_no":"29419090","bill_no":"5590936","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVAKIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BRATISLAVA","supplierAddress":"976 13 SLOVENSKA LUPCA 566 SLOVAK REPUBLIC SDNF SLOVAK REPUBLIC","customerAddress":"NO 31, RACE COURSE ROAD,BANGALORE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726252200,"product":"POLYMYXIN B SULFATE USP","address":"194 ARVIND CHAMBERS 07 SAI SERVICE","city":"MUMBAI,MAHARASHTRA","supplier":"CHEMEXCEL INTERNATIONAL LIMITED","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"RIFA PHARMA","customerCountry":"INDIA","quantity":"0.88","actualQuantity":"0.875","unit":"KGS","unitRateFc":"4950","totalValueFC":"4388","currency":"USD","unitRateINR":"420255","date":"14-Sep-2024","totalValueINR":"367723.13","totalValueInUsd":"4388","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"5603956","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"RM#801-2,8\/F., EASEY COMMERCIAL BUI LDING , 253-261 HENNESSY ROAD, WANC HAI, HONG K ONG , , Hong Kong","customerAddress":"194 ARVIND CHAMBERS 07 SAI SERVICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728844200,"product":"POLYMYXIN B SULFATE (A200-000) POLYMYXIN B SULFATE (A200-000)","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"BIOTIKA A.S.","supplierCountry":"SLOVAKIA","foreign_port":"BRATISLAVA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2.50","actualQuantity":"2.5","unit":"KGS","unitRateFc":"4887.4","totalValueFC":"12338.4","currency":"USD","unitRateINR":"414700","date":"14-Oct-2024","totalValueINR":"1036750","totalValueInUsd":"12338.4","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29419019","bill_no":"6112498","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVAKIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BRATISLAVA","supplierAddress":"SLOVENSKA LUPCA 566 976 13 SLOVENSKA LUPCA SDNF SK","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731954600,"product":"POLYMYXIN B SULFATE USP (NON -STERILE) [QTY.: 78.60 BOU]","address":"UNIT NO.24 STEEL MADE INDL.ESTATE","city":"MUMBAI","supplier":"TRIO PHARMACEUTICAL INC","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"ENCUBE ETHICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"9.38","actualQuantity":"9.375","unit":"KGS","unitRateFc":"5575.4","totalValueFC":"52833.8","currency":"USD","unitRateINR":"475578.2","date":"19-Nov-2024","totalValueINR":"4458545.7","totalValueInUsd":"52833.8","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"6759666","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"ROOM 910,255 XIN JINQIAO ROAD PUDONG, SHANGHAI SDNF CN","customerAddress":"UNIT NO.24 STEEL MADE INDL.ESTATE"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

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FDF Dossiers

01

Allergan Aesthetics

U.S.A

PharmaVenue

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Regulatory Info : DISCN

Registration Country : USA

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE

Brand Name : POLY-PRED

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.35% BASE;10,000 UNITS/ML;0.5%

Packaging :

Approval Date : 1982-01-01

Application Number : 50081

Regulatory Info : DISCN

Registration Country : USA

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

02

Allergan Aesthetics

U.S.A

PharmaVenue

Not Confirmed

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Regulatory Info : DISCN

Registration Country : USA

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

Brand Name : POLYTRIM

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 10,000 UNITS/ML;EQ 1MG BASE/ML

Packaging :

Approval Date : 1988-10-20

Application Number : 50567

Regulatory Info : DISCN

Registration Country : USA

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

03

Naprod Life Sciences

India

PharmaVenue

Not Confirmed

Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

Polymyxin B Sulfate

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 500000IU

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Product Web Link

Corporate PDF

04

Bausch & Lomb Incorporated

Canada

PharmaVenue

Not Confirmed

05

Bausch & Lomb Incorporated

Canada

PharmaVenue

Not Confirmed

06

Bausch & Lomb Incorporated

Canada

PharmaVenue

Not Confirmed

07

Hanlim Pharmaceuticals Inc

South Korea

PharmaVenue

Not Confirmed

08

Pfizer Inc

U.S.A

PharmaVenue

Not Confirmed

09

Sandoz B2B

Switzerland

PharmaVenue

Not Confirmed

10

Somerset Pharmaceuticals Inc

U.S.A

PharmaVenue

Not Confirmed

Only 10 entries up to this point, click to access all

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FDA Orange Book

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Europe

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Canada

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South Africa

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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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 - 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

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

USFDA APPLICATION NUMBER - 50567

Related Excipient Companies

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Excipients by Applications

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Coating Systems & Additives

Topical

Solubilizers

Parenteral

01

Seqens

France

PharmaVenue

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

Dosage Form : Injectable / Parenteral

Grade : Parenteral

Category : Parenteral

Brand Name : Expansorb® PLA / PEG

Application : Parenteral

Excipient Details : Expansorb® PLA?/PEG? polymers are used as functional excipients in injectable formulations for controlled & slow drug release with a single injection.

Pharmacopoeia Ref : N/A

Technical Specs : Classic and ultrapure LMP

Ingredient(s) : Poly lactic acid

02

Nanjing Well Pharmaceutical

China

PharmaVenue

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet

Grade : Parenteral, Oral, Topical

Category : Emulsifying Agents, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Brand Name : Polysorbate 20

Application : Emulsifying Agents, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Excipient Details : Polysorbate 20 is used in parenteral products such as biologics. It is used as a solubilizer, surfactant, emulsifier & suspension stabilizer.

Pharmacopoeia Ref : ChP/USP/EP

Technical Specs : NA

Ingredient(s) : Polysorbate 20

03

Pfanstiehl

U.S.A

PharmaVenue

Not Confirmed

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

Category : Parenteral, Thickeners and Stabilizers

Brand Name : Sucrose

Application : Parenteral, Thickeners and Stabilizers

Excipient Details : Sucrose is used to stabilize proteins, lipids, carbohydrates, ADCs & vaccines. It is also used as a cryopreservative in cell-based bioprocesses.

Pharmacopoeia Ref : USDMF, NF, EP, JP, ChP

Technical Specs : N/A

Ingredient(s) : Sucrose

04

Seqens

France

PharmaVenue

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

Dosage Form : Injectable / Parenteral

Grade : Parenteral

Category : Parenteral

Brand Name : Expansorb® PLGA / PEG

Application : Parenteral

Excipient Details : Expansorb® PLGA? / PEG copolymers are used as functional excipients in single dose injections for controlled and slow drug release (weeks to months).

Pharmacopoeia Ref : N/A

Technical Specs : Classic and ultrapure LMP

Ingredient(s) : Poly-DL-Lactic-co-Glycolic Acid

05

Pluviaendo

Turkey

PharmaVenue

Not Confirmed

06

Nanjing Well Pharmaceutical

China

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet

Grade : Parenteral, Oral, Topical

Category : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Brand Name : Polysorbate 80

Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Polysorbate 80

07

Nanjing Well Pharmaceutical

China

PharmaVenue

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Capsule, Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Solution, Suspension, Tablet

Grade : Parenteral, Oral, Topical

Category : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Thickeners and Stabilizers, Topical

Brand Name : Poloxamer 188

Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Thickeners and Stabilizers, Topical

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

08

Nippon Fine Chemical

Japan

PharmaVenue

Not Confirmed

09

Nanjing Well Pharmaceutical

China

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgels

Grade : Parenteral, Oral, Topical

Category : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical

Brand Name : Propylene Glycol

Application : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical

Excipient Details : Propylene glycol is used as a solvent & stabilizer in injections. It is also used in topical semi-solids & as a plasticizer in soft capsules.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Propylene Glycol

10

Nanjing Well Pharmaceutical

China

PharmaVenue

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Injectable / Parenteral

Grade : Parenteral

Category : Parenteral

Brand Name : Squalene

Application : Parenteral

Excipient Details : Squalene is used as a antioxidant, Influenza vaccine adjuvant, and core ingredient in MF59 emulsions.

Pharmacopoeia Ref : EP

Technical Specs : Store at 2-8 ° C

Ingredient(s) : Squalene

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Surfactant & Foaming Agents

Direct Compression

Granulation

Fillers, Diluents & Binders

API Stability Enhancers

Lubricants & Glidants

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ABOUT THIS PAGE

Polymyxin B Sulfate Manufacturers

A Polymyxin B Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polymyxin B Sulfate, including repackagers and relabelers. The FDA regulates Polymyxin B Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polymyxin B 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 Polymyxin B Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Polymyxin B Sulfate Suppliers

A Polymyxin B Sulfate supplier is an individual or a company that provides Polymyxin B Sulfate active pharmaceutical ingredient (API) or Polymyxin B Sulfate finished formulations upon request. The Polymyxin B Sulfate suppliers may include Polymyxin B Sulfate API manufacturers, exporters, distributors and traders.

click here to find a list of Polymyxin B Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Polymyxin B Sulfate USDMF

A Polymyxin B Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Polymyxin B Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Polymyxin B Sulfate DMFs exist exist since differing nations have different regulations, such as Polymyxin B Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Polymyxin B Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Polymyxin B Sulfate USDMF includes data on Polymyxin B Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polymyxin B Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Polymyxin B Sulfate suppliers with USDMF on PharmaCompass.

Polymyxin B Sulfate JDMF

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 Polymyxin B Sulfate Drug Master File in Japan (Polymyxin B Sulfate JDMF) empowers Polymyxin B 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 Polymyxin B Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Polymyxin B 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 Polymyxin B Sulfate suppliers with JDMF on PharmaCompass.

Polymyxin B Sulfate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Polymyxin B Sulfate Drug Master File in Korea (Polymyxin B Sulfate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Polymyxin B Sulfate. The MFDS reviews the Polymyxin B Sulfate KDMF as part of the drug registration process and uses the information provided in the Polymyxin B Sulfate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Polymyxin B 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 Polymyxin B Sulfate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Polymyxin B Sulfate suppliers with KDMF on PharmaCompass.

Polymyxin B Sulfate CEP

A Polymyxin B Sulfate CEP of the European Pharmacopoeia monograph is often referred to as a Polymyxin B Sulfate Certificate of Suitability (COS). The purpose of a Polymyxin B Sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Polymyxin B Sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Polymyxin B Sulfate to their clients by showing that a Polymyxin B Sulfate CEP has been issued for it. The manufacturer submits a Polymyxin B Sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Polymyxin B Sulfate CEP holder for the record. Additionally, the data presented in the Polymyxin B Sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Polymyxin B Sulfate DMF.

A Polymyxin B Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Polymyxin B 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 Polymyxin B Sulfate suppliers with CEP (COS) on PharmaCompass.

Polymyxin B Sulfate WC

A Polymyxin B Sulfate written confirmation (Polymyxin B Sulfate WC) is an official document issued by a regulatory agency to a Polymyxin B Sulfate manufacturer, verifying that the manufacturing facility of a Polymyxin B Sulfate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Polymyxin B Sulfate APIs or Polymyxin B Sulfate finished pharmaceutical products to another nation, regulatory agencies frequently require a Polymyxin B Sulfate WC (written confirmation) as part of the regulatory process.

click here to find a list of Polymyxin B Sulfate suppliers with Written Confirmation (WC) on PharmaCompass.

Polymyxin B Sulfate NDC

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 Polymyxin B Sulfate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Polymyxin B Sulfate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Polymyxin B 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Polymyxin B Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Polymyxin B Sulfate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Polymyxin B Sulfate suppliers with NDC on PharmaCompass.

Polymyxin B Sulfate GMP

Polymyxin B 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 Polymyxin B 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 Polymyxin B Sulfate GMP manufacturer or Polymyxin B Sulfate GMP API supplier for your needs.

Polymyxin B Sulfate CoA

A Polymyxin B Sulfate CoA (Certificate of Analysis) is a formal document that attests to Polymyxin B Sulfate's compliance with Polymyxin B Sulfate specifications and serves as a tool for batch-level quality control.

Polymyxin B Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Polymyxin B 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.

Polymyxin B Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Polymyxin B Sulfate EP), Polymyxin B Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Polymyxin B Sulfate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

Find Polymyxin B Sulfate manufacturers, exporters & distributors on PharmaCompass

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

32 API Suppliers

13 USDMF

6 CEP/COS

2 JDMF

1 EU WC

2 KDMF

20 NDC API

21 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

7 Drugs in Development

FINISHED DOSAGE FORMULATIONS

144 FDF Dossiers

95 FDA Orange Book

7 Europe

19 Canada

7 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

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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 Granulation

7 Fillers, Diluents & Binders

5 API Stability Enhancers

5 Lubricants & Glidants

5 Empty Capsules

4 Vegetarian 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