Lesvi Brand of Azithromycin Dihydrate

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ACTIVE PHARMA INGREDIENTS

82 API Suppliers, 26 USDMF, 9 CEP/COS, 8 JDMF, 9 EU WC, 12 KDMF, 3 NDC API, 43 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

22 Drugs in Development

22 Drugs in Development

INTERMEDIATES

6 Intermediate Suppliers

6 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

602 FDF Dossiers, 86 FDA Orange Book, 208 Europe, 14 Canada, 29 Australia, 27 South Africa, 238 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SUSPENSION;ORAL - EQ 1GM BASE/PACKET, FOR SUSPENSION;ORAL - EQ 100MG BASE/5ML, FOR SUSPENSION;ORAL - EQ 200MG BASE/5ML, TABLET;ORAL - EQ 250MG BASE, TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL, TABLET;ORAL - EQ 500MG BASE, FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM BASE/BOT

RELATED EXCIPIENT COMPANIES

5 Evonik, 4 Rochem International Inc, 21 SPI Pharma, 7 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 6 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 18 BASF, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 9 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 33 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 1 Lubrizol Life Science Health, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 4 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, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

76 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 32 Disintegrants & Superdisintegrants, 32 Controlled & Modified Release, 30 Direct Compression, 30 Thickeners and Stabilizers, 29 Taste Masking, 25 Granulation, 19 Chewable & Orodispersible Aids, 17 Lubricants & Glidants, 16 Solubilizers, 15 Topical, 14 Parenteral, 14 Film Formers & Plasticizers, 14 Co-Processed Excipients, 7 API Stability Enhancers, 7 Emulsifying Agents, 7 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 98 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 208 Regulatory FDF Prices, 10 Annual Reports

MARKET PLACE

85 APIs, 38 FDF Dossiers, 1 Intermediates

PATENTS & EXCLUSIVITIES

3 Health Canada Patents

3 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 6 USP, 9 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 50711 / DOSAGE - TABLET;ORAL - EQ 250MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AZITHROMYCIN DIHYDRATE(UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)	AZITHROMYCIN ANHYDROUS	250mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Cardinal Health	Department of State Health Services, Pharmacy Branch	Lake Erie Medical DBA Quality Care Products LLC	PD-Rx Pharmaceuticals, Inc.	Preferred Pharmaceuticals, Inc.	REMEDYREPACK INC.	Aidarex Pharmaceuticals LLC	Bionpharma Inc.	Cardinal Health 107, LLC	Central Texas Community Health Centers	DIRECT RX	Doc Rx	Major Pharmaceuticals	Northwind Pharmaceuticals	NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals, Inc..	NuCare Pharmaceuticals,Inc.	PharmPak, Inc.	Proficient Rx LP	RPK Pharmaceuticals, Inc.	Teva Pharmaceuticals USA, Inc.	Unit Dose Services	American Health Packaging	Alembic Pharmaceuticals Inc.	Direct_Rx	LUPIN LIMITED	Lupin Pharmaceuticals, Inc.	Medsource Pharmaceuticals	NuCare Pharmaceuticals, Inc.	Avera McKennan Hospital	AvPAK	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	Lannett Company, Inc.	Quality Care Products, LLC	Sunshine Lake Pharma Co., Ltd.	Vivimed Labs Limited	Wockhardt USA LLC.	Apotex Corp.	REMEDYREPACK INC.	Bryant Ranch Prepack	McKesson Corporation	Preferred Pharmaceuticals Inc.	Sandoz Inc	Teva Ph	Teva Pharmaceuticals	Teva P
ALUMINUM OXIDE(LMI26O6933)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)
CARMINIC ACID(CID8Z8N95N)
CELLULOSE, MICROCRYSTALLINE (OP1R32D61U)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COCHINEAL(TZ8Z31B35M)
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (M28OL1HH48)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C RED NO. 30(2S42T2808B)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
HYDROXYPROPYL CELLULOSE (RFW2ET671P)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (TYPE E)(66O7AQV0RT)
Hydroxypropyl Cellulose (Type H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
LECITHIN, SOYBEAN(1DI56QDM62)
MAGNESIUM STEARATE (70097M6I30)
MAGNESIUM STEARATE(70097M6I30)
MAGNESIUM TRISILICATE (C2E1CI501T)
Magnesium Trisilicate(C2E1CI501T)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
PIGMENT RED 5(91OZU993LX)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS (3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
SILICON DIOXIDE (ETJ7Z6XBU4)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN (O8232NY3SJ)
STARCH, CORN(O8232NY3SJ)
STARCH, PREGELATINIZED CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE (15FIX9V2JP)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
TRISODIUM CITRATE DIHYDRATE(B22547B95K)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Lesvi Brand of Azithromycin Dihydrate