(22S)-BUDESONIDE

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ACTIVE PHARMA INGREDIENTS

85 API Suppliers, 24 USDMF, 28 CEP/COS, 7 JDMF, 7 EU WC, 15 KDMF, 36 NDC API, 44 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

76 Drugs in Development

76 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

629 FDF Dossiers, 54 FDA Orange Book, 429 Europe, 23 Canada, 19 Australia, 39 South Africa, 65 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 9MG, AEROSOL, FOAM;RECTAL - 2MG/ACTUATION, SPRAY, METERED;NASAL - 0.032MG/SPRAY, SUSPENSION;INHALATION - 0.25MG/2ML, SUSPENSION;INHALATION - 0.5MG/2ML, SUSPENSION;INHALATION - 1MG/2ML, CAPSULE, DELAYED RELEASE;ORAL - 6MG, CAPSULE, DELAYED RELEASE;ORAL - 9MG, CAPSULE, DELAYED RELEASE;ORAL - 3MG, AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH, AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH

RELATED EXCIPIENT COMPANIES

4 Evonik, 1 Rochem International Inc, 5 SPI Pharma, 13 DKSH, 4 Faran Shimi Pharmaceutical, 3 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 1 Clariant, 14 Corel Pharma Chem, 4 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 10 Gangwal Chemicals, 9 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 31 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 18 Roquette, 14 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 4 The Dow Chemical Company, 2 Valens Pharmachem, 2 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

69 Coating Systems & Additives, 63 Fillers, Diluents & Binders, 41 Controlled & Modified Release, 36 Thickeners and Stabilizers, 25 Solubilizers, 22 Direct Compression, 21 Film Formers & Plasticizers, 20 Granulation, 19 Taste Masking, 18 Topical, 18 Lubricants & Glidants, 13 Parenteral, 11 Co-Processed Excipients, 10 Rheology Modifiers, 9 Emulsifying Agents, 9 Empty Capsules, 9 Disintegrants & Superdisintegrants, 6 Chewable & Orodispersible Aids, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 131 News #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 232 Regulatory FDF Prices, 37 Annual Reports

MARKET PLACE

19 APIs, 17 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

54 US Patents, 4 US Exclusivities, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 21 USP, 13 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 203634 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 9MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUDESONIDE(UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)	BUDESONIDE	9mg

Inactive Ingredients

Ingredient Name	Golden State Medical Supply Inc.	Santarus Inc.
FERROSOFERRIC OXIDE(XM0M87F357)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
LECITHIN, SOYBEAN(1DI56QDM62)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYSORBATE 80(6OZP39ZG8H)
PROPYLENE GLYCOL(6DC9Q167V3)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STEARIC ACID(4ELV7Z65AP)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)

Drug Product Composition: (22S)-BUDESONIDE

(22S)-BUDESONIDE

(22S)-BUDESONIDE

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

85 API Suppliers

24 USDMF

28 CEP/COS

7 JDMF

7 EU WC

15 KDMF

36 NDC API

44 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

76 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

629 FDF Dossiers

54 FDA Orange Book

429 Europe

23 Canada

19 Australia

39 South Africa

65 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 9MG

AEROSOL, FOAM;RECTAL - 2MG/ACTUATION

SPRAY, METERED;NASAL - 0.032MG/SPRAY

SUSPENSION;INHALATION - 0.25MG/2ML

SUSPENSION;INHALATION - 0.5MG/2ML

SUSPENSION;INHALATION - 1MG/2ML

CAPSULE, DELAYED RELEASE;ORAL - 6MG

CAPSULE, DELAYED RELEASE;ORAL - 9MG

CAPSULE, DELAYED RELEASE;ORAL - 3MG

AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH

AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH

RELATED EXCIPIENT COMPANIES

4 Evonik

1 Rochem International Inc

5 SPI Pharma

13 DKSH

4 Faran Shimi Pharmaceutical

3 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Pfanstiehl

4 ACG Worldwide

11 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

23 BASF

1 Clariant

14 Corel Pharma Chem

4 DFE Pharma

3 Doshion Polyscience

2 Finar

10 Gangwal Chemicals

9 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

31 Kerry

5 Kima Chemical

6 Lonza Capsugel

16 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

1 Novo Excipients

1 Pharmatrans-Sanaq

5 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

18 Roquette

14 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries