Hydrocortisone USP

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400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 1%, LOTION;TOPICAL - 2%, TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 5MG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

MARKET PLACE

35 APIs, 17 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 3 JP, 27 Others

ANALYTICAL

2 BioAnalytical Methods, 4 Analytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 80693 / DOSAGE - CREAM;TOPICAL - 1%

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Hydrocortisone(UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	10mg in 1

Inactive Ingredients

Ingredient Name	Lake Erie Medical DBA Quality Care Products LLC
benzyl alcohol(LKG8494WBH)
glycerin(PDC6A3C0OX)
glyceryl monostearate(230OU9XXE4)
ISOPROPYL PALMITATE(8CRQ2TH63M)
LACTIC ACID(33X04XA5AT)
PARAFFIN(I9O0E3H2ZE)
POLYOXYL 40 STEARATE(13A4J4NH9I)
POTASSIUM SORBATE(1VPU26JZZ4)
SORBITAN MONOSTEARATE(NVZ4I0H58X)
STEARYL ALCOHOL(2KR89I4H1Y)
water(059QF0KO0R)

Setid Cc58ae80 1f86 477b A2c7 E4c6d4a4ff0f Applno 80693 Form Cream Topical Dosage 1 - Drug Product Composition: Hydrocortisone USP