1,25-dihydroxy vitamin D3 | 18044 | CAPSULE;ORAL | 0.5MCG

1,25 DIHYDROXY VITAMIN D3

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ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 13 USDMF, 8 CEP/COS, 3 JDMF, 1 EU WC, 5 KDMF, 9 NDC API, 24 Listed Suppliers, $ API Reference Price

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

128 FDF Dossiers, 35 FDA Orange Book, 40 Europe, 10 Canada, 24 Australia, 1 South Africa, 18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 0.25MCG, CAPSULE;ORAL - 0.5MCG, INJECTABLE;INJECTION - 0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 16 SPI Pharma, 8 DKSH, 7 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 BASF, 1 Finar, 3 Gangwal Chemicals, 3 Ingredion Pharma Solutions, 4 Kerry, 3 Lonza Capsugel, 2 Microlex e.U, 3 Pluviaendo, 1 Qualicaps, 19 Roquette, 4 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 1 Valens Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

37 Fillers, Diluents & Binders, 18 Direct Compression, 16 Parenteral, 16 Taste Masking, 14 Chewable & Orodispersible Aids, 12 Film Formers & Plasticizers, 10 Coating Systems & Additives, 9 Co-Processed Excipients, 9 Thickeners and Stabilizers, 8 Empty Capsules, 8 Solubilizers, 8 Topical, 7 Disintegrants & Superdisintegrants, 4 Granulation, 3 Coloring Agents, 3 Controlled & Modified Release, 2 Emulsifying Agents, 2 Surfactant & Foaming Agents, 1 Soft Gelatin, 1 API Stability Enhancers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 5 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 46 Finished Drug Prices, 7 Annual Reports

MARKET PLACE

9 APIs, 12 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 2 Others

$ Xls

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USFDA APPLICATION NUMBER - 18044 / DOSAGE - CAPSULE;ORAL - 0.5MCG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCITRIOL(UNII: FXC9231JVH) (CALCITRIOL - UNII:FXC9231JVH)	CALCITRIOL	0.5ug \| 0.25ug

Inactive Ingredients

Ingredient Name	Cardinal Health	Teva Pharmaceuticals USA Inc	American Health Packaging	Amneal Pharmaceuticals LLC	Avera McKennan Hospital	BIONPHARMA INC.	Bryant Ranch Prepack	Golden State Medical Supply, Inc.	Heritage Pharmaceuticals Inc	KAISER FOUNDATION HOSPITALS	NuCare Pharmaceuticals,Inc.
AMMONIA(5138Q19F1X)
BUTYLATED HYDROXYANISOLE(REK4960K2U)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
COCONUT OIL(Q9L0O73W7L)
FD&C RED NO. 3(PN2ZH5LOQY)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GLYCERIN(PDC6A3C0OX)
ISOPROPYL ALCOHOL(ND2M416302)
MANNITOL(3OWL53L36A)
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)
METHYLPARABEN SODIUM(CR6K9C2NHK)
METHYLPARABEN(A2I8C7HI9T)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLPARABEN SODIUM(625NNB0G9N)
PROPYLPARABEN(Z8IX2SC1OH)
SHELLAC(46N107B71O)
SORBITAN(6O92ICV9RU)
SORBITOL(506T60A25R)
STARCH, CORN(O8232NY3SJ)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)

Drug Product Composition: 1,25-dihydroxy vitamin D3