Montelukast Sodium

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

86 API Suppliers, 33 USDMF, 19 CEP/COS, 19 JDMF, 17 EU WC, 23 KDMF, 17 NDC API, 49 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

INTERMEDIATES

25 API Suppliers

25 API Suppliers

FINISHED DOSAGE FORMULATIONS

703 FDF Dossiers, 73 FDA Orange Book, 368 Europe, 48 Canada, 11 Australia, 73 South Africa, 130 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET, CHEWABLE;ORAL - EQ 4MG BASE, TABLET, CHEWABLE;ORAL - EQ 5MG BASE, GRANULE;ORAL - EQ 4MG BASE/PACKET

RELATED EXCIPIENT COMPANIES

1 Minakem, 4 Rochem International Inc, 18 SPI Pharma, 2 Seqens, 11 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 2 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 20 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 25 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

96 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 45 Direct Compression, 33 Disintegrants & Superdisintegrants, 30 Controlled & Modified Release, 27 Granulation, 25 Thickeners and Stabilizers, 25 Taste Masking, 24 Lubricants & Glidants, 19 Chewable & Orodispersible Aids, 17 Co-Processed Excipients, 15 Film Formers & Plasticizers, 14 Topical, 14 Parenteral, 12 Solubilizers, 6 API Stability Enhancers, 5 Emulsifying Agents, 5 Empty Capsules, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

45 NEWS #PharmaBuzz

45 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 334 Finished Drug Prices, 10 Annual Reports

MARKET PLACE

51 APIs, 7 FDF Dossiers, 1 Intermediates

PATENTS & EXCLUSIVITIES

8 Health Canada Patents

8 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 4 USP, 10 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 20829 / DOSAGE - TABLET;ORAL - EQ 10MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MONTELUKAST SODIUM(UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)	MONTELUKAST	10mg

Inactive Ingredients

Ingredient Name	Accord Healthcare Inc.	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NuCare Pharmaceuticals,Inc.	PD-Rx Pharmaceuticals, Inc.	REMEDYREPACK INC.	Apotex Corp	Cardinal Health	Legacy Pharmaceutical Packaging, LLC	A-S Medication Solutions	A-S Medication Solutions LLC	ACETRIS HEALTH, LLC	ASE Direct, Inc.	Bionpharma Inc.	Bryant Ranch Prepack	Lake Erie Medical DBA Quality Care Products LLC	Merck Sharp & Dohme Corp.	Mylan Pharmaceuticals Inc.	Par Pharmaceutical	Physicians Total Care, Inc.	Teva Pharmaceuticals USA, Inc.	BluePoint Laboratories	Glenmark Pharmaceuticals Inc., USA	Avera McKennan Hospital	Clinical Solutions Wholesale	Graviti Pharmaceuticals Private Limited	Major Pharmaceuticals	Method Pharmaceuticals, LLC	NCS HealthCare of KY, Inc dba Vangard Labs	Rising Pharma Holdings, Inc.	Torrent Pharmaceuticals Limited	Hikma Pharmaceuticals USA Inc.	DIRECT RX	Mylan Institutional Inc.	Preferred Pharmaceuticals Inc.	Proficient Rx LP	RPK Pharmaceuticals, Inc.	International Laboratories, LLC	MedVantx, Inc.	QPharma Inc	Teva Pharmaceuticals US
POLYETHYLENE GLYCOL 6000 (30IQX730WE)
ANHYDROUS LACTOSE(3SY5LH9PMK)
ASPARTAME(Z0H242BBR1)
CARNAUBA WAX(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CHERRY(BUC5I9595W)
COPOVIDONE K25-31(D9C330MD8B)
CROSCARMELLOSE SODIUM(M28OL1HH48)
EDETATE DISODIUM(7FLD91C86K)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
ferric oxide red(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE L)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)
HYPROMELLOSE 2208 (15000 CPS)(Z78RG6M2N2)
HYPROMELLOSE 2910 (15000 MPA.S)(288VBX44JC)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
ISOPROPYL ALCOHOL(ND2M416302)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MALTODEXTRIN(7CVR7L4A2D)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 6000(30IQX730WE)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM PHOSPHATE, TRIBASIC(A752Q30A6X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
STARCH, CORN(O8232NY3SJ)
SUCRALOSE(96K6UQ3ZD4)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Drug Product Composition: Montelukast Sodium