Desloratadine

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ACTIVE PHARMA INGREDIENTS

54 API Suppliers, 16 USDMF, 13 CEP/COS, 20 EU WC, 3 KDMF, 11 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

283 FDF Dossiers, 24 FDA Orange Book, 153 Europe, 5 Canada, 49 South Africa, 52 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 5MG, SOLUTION;ORAL - 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 2.5MG;120MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 3 Rochem International Inc, 22 SPI Pharma, 2 Seqens, 3 DKSH, 3 Jai Radhe Sales, 7 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 28 BASF, 12 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 2 Finar, 11 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 29 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

90 Fillers, Diluents & Binders, 57 Coating Systems & Additives, 45 Direct Compression, 35 Controlled & Modified Release, 34 Disintegrants & Superdisintegrants, 30 Granulation, 27 Thickeners and Stabilizers, 26 Taste Masking, 26 Lubricants & Glidants, 23 Solubilizers, 21 Film Formers & Plasticizers, 20 Chewable & Orodispersible Aids, 20 Co-Processed Excipients, 19 Parenteral, 16 Topical, 8 Emulsifying Agents, 8 API Stability Enhancers, 5 Empty Capsules, 4 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 5 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 114 Finished Drug Prices, 6 Annual Reports

MARKET PLACE

27 APIs, 10 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

7 Health Canada Patents

7 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 USP, 17 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21165 / DOSAGE - TABLET;ORAL - 5MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Desloratadine(UNII: FVF865388R) (Desloratadine - UNII:FVF865388R)	Desloratadine	0.5mg in 1 \| 5mg

Inactive Ingredients

Ingredient Name	Merck Sharp & Dohme Corp.	Paddock Laboratories, LLC	AvKARE, Inc.	AvPAK	Bryant Ranch Prepack	Sandoz Inc	A-S Medication Solutions	Virtus Pharmaceuticals	Mylan Pharmaceuticals Inc.
Aluminum Oxide(LMI26O6933)
anhydrous citric acid(XF417D3PSL)
CARNAUBA WAX(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)
edetate disodium(7FLD91C86K)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FD&C Yellow No. 6(H77VEI93A8)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
lactose monohydrate(EWQ57Q8I5X)
MAGNESIUM HYDROXIDE(NBZ3QY004S)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
propylene glycol(6DC9Q167V3)
SILICON DIOXIDE(ETJ7Z6XBU4)
sodium benzoate(OJ245FE5EU)
SODIUM LAURYL SULFATE(368GB5141J)
sorbitol(506T60A25R)
STARCH, CORN(O8232NY3SJ)
sucrose(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
trisodium citrate dihydrate(B22547B95K)
water(059QF0KO0R)
white wax(7G1J5DA97F)
ZINC STEARATE(H92E6QA4FV)

Drug Product Composition: Desloratadine

Desloratadine

Desloratadine

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

54 API Suppliers

16 USDMF

13 CEP/COS

20 EU WC

3 KDMF

11 NDC API

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

283 FDF Dossiers

24 FDA Orange Book

153 Europe

5 Canada

49 South Africa

52 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 5MG

SOLUTION;ORAL - 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 2.5MG;120MG

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Evonik

3 Rochem International Inc

22 SPI Pharma

2 Seqens

3 DKSH

3 Jai Radhe Sales

7 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

15 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 ACG Worldwide

9 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

28 BASF

12 Corel Pharma Chem

7 DFE Pharma

1 Doshion Polyscience

2 Finar

11 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

3 Kima Chemical

6 Lonza Capsugel

16 Microlex e.U

1 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

7 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

29 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

12 Sigachi Industries

2 The Dow Chemical Company

2 Valens Pharmachem

4 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

SOLUTION;ORAL - 0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons