Hydrocortisone

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ACTIVE PHARMA INGREDIENTS

84 API Suppliers, 29 USDMF, 14 CEP/COS, 6 JDMF, 9 EU WC, 10 KDMF, 40 NDC API, 1 VMF, 33 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

59 Drugs in Development

59 Drugs in Development

FINISHED DOSAGE FORMULATIONS

459 FDF Dossiers, 234 FDA Orange Book, 152 Europe, 14 Canada, 8 Australia, 28 South Africa, 23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%, CREAM;TOPICAL - 5%;1%, 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- 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 1%, LOTION;TOPICAL - 2%, TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 Rochem International Inc, 8 SPI Pharma, 17 DKSH, 1 Pharm-RX Chemical, 6 Gangwal Healthcare, 24 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 4 Pfanstiehl, 23 Kirsch Pharma, 22 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 42 BASF, 3 BioSpectra, 4 CD Formulation, 1 Clariant, 15 Corel Pharma Chem, 7 DFE Pharma, 3 Esteem Industries, 6 Finar, 16 Gangwal Chemicals, 2 Hayashibara, 2 Ideal Cures, 4 Ingredion Pharma Solutions, 19 Kerry, 3 Keval Exports, 9 Lubrizol Life Science Health, 17 Microlex e.U, 3 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 33 Roquette, 21 Seppic, 2 Shandong Focus Biotechnology Co., Ltd, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 5 Silverline Chemicals, 1 Symrise, 2 Valens Pharmachem, 5 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

92 Topical, 64 Thickeners and Stabilizers, 60 Solubilizers, 59 Parenteral, 57 Fillers, Diluents & Binders, 36 Direct Compression, 33 Emulsifying Agents, 33 Granulation, 28 Lubricants & Glidants, 27 Coating Systems & Additives, 27 Disintegrants & Superdisintegrants, 23 Surfactant & Foaming Agents, 23 Controlled & Modified Release, 20 Film Formers & Plasticizers, 18 Taste Masking, 14 Co-Processed Excipients, 12 Chewable & Orodispersible Aids, 10 Rheology Modifiers, 6 API Stability Enhancers, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 49 News #PharmaBuzz

GLOBAL SALES INFORMATION

38 US Medicaid Prescriptions, 77 Regulatory FDF Prices, 1 Annual Reports

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35 APIs, 17 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

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ANALYTICAL

2 BioAnalytical Methods, 4 Analytical Methods

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USFDA APPLICATION NUMBER - 8697 / DOSAGE - TABLET;ORAL - 5MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE(UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	5mg

Inactive Ingredients

Ingredient Name	Major Pharmaceuticals	PD-Rx Pharmaceuticals, Inc.	West-Ward Pharmaceuticals Corp	Avera McKennan Hospital	KAISER FOUNDATION HOSPITALS	Pharmacia & Upjohn Company LLC	American Health Packaging	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Lineage Therapeutics Inc	Par Pharmaceutical	Strides Pharma Inc.	Bryant Ranch Prepack
ANHYDROUS LACTOSE(3SY5LH9PMK)
CALCIUM STEARATE(776XM7047L)
Cellulose, Microcrystalline(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
Lactose Monohydrate(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
MINERAL OIL(T5L8T28FGP)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SODIUM STARCH GLYCOLATE TYPE B POTATO(27NA468985)
SORBIC ACID(X045WJ989B)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)

Setid Bfb94431 4b69 4780 B7d7 E3999e444c39 Applno 8697 Form Tablet Oral Dosage 5mg - Drug Product Composition: Hydrocortisone

Hydrocortisone

Hydrocortisone

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

84 API Suppliers

29 USDMF

14 CEP/COS

6 JDMF

9 EU WC

10 KDMF

40 NDC API

1 VMF

33 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

59 Drugs in Development

FINISHED DOSAGE FORMULATIONS

459 FDF Dossiers

234 FDA Orange Book

152 Europe

14 Canada

8 Australia

28 South Africa

23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%

CREAM;TOPICAL - 5%;1%

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 - 1%

LOTION;TOPICAL - 2%

TABLET;ORAL - 10MG

TABLET;ORAL - 20MG

TABLET;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

4 Rochem International Inc

8 SPI Pharma

17 DKSH

1 Pharm-RX Chemical

6 Gangwal Healthcare

24 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

4 Pfanstiehl

23 Kirsch Pharma

22 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

42 BASF

3 BioSpectra

4 CD Formulation

1 Clariant

15 Corel Pharma Chem

7 DFE Pharma

3 Esteem Industries

6 Finar

16 Gangwal Chemicals

2 Hayashibara

2 Ideal Cures

4 Ingredion Pharma Solutions

19 Kerry

3 Keval Exports

9 Lubrizol Life Science Health

17 Microlex e.U

3 Nanjing Bold Chemical

2 Nippon Fine Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Chemical

33 Roquette

21 Seppic

2 Shandong Focus Biotechnology Co., Ltd

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu 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