Azithromycin, unspecified form

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ACTIVE PHARMA INGREDIENTS

69 API Suppliers, 26 USDMF, 9 CEP/COS, 8 JDMF, 9 EU WC, 12 KDMF, 2 NDC API, 40 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

21 Drugs in Development

21 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

570 FDF Dossiers, 86 FDA Orange Book, 208 Europe, 13 Canada, 28 Australia, 27 South Africa, 208 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- EQ 250MG BASE, TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL, TABLET;ORAL - EQ 500MG BASE, FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM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

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1 Evonik, 4 Rochem International Inc, 20 SPI Pharma, 2 Seqens, 5 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 12 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, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

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GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 208 Finished Drug Prices, 10 Annual Reports

MARKET PLACE

80 APIs, 38 FDF Dossiers, 1 Intermediates

PATENTS & EXCLUSIVITIES

2 US Patents, 3 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 8 USP, 9 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 50710 / DOSAGE - FOR SUSPENSION;ORAL - EQ 100MG BASE/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AZITHROMYCIN DIHYDRATE(UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)	AZITHROMYCIN ANHYDROUS	100mg in 5

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Preferred Pharmaceuticals, Inc.	Teva Pharmaceuticals USA, Inc.	NuCare Pharmaceuticals,Inc.	Preferred Pharmaceuticals Inc.	Proficient Rx LP	Quality Care Products LLC	Quality Care Products, LLC	RPK Pharmaceuticals, Inc.	Clinical Solutions Wholesale	Lake Erie Medical DBA Quality Care Products LLC	REMEDYREPACK INC.	STATE HEALTH SERVICES, TEXAS DEPARTMENT OF	Rebel Distributors Corp.	Amneal Pharmaceuticals LLC	Lupin Pharmaceuticals,Inc.	Zydus Pharmaceuticals USA Inc.
ACACIA(5C5403N26O)
BANANA(4AJZ4765R9)
CHERRY(BUC5I9595W)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(905HNO1SIH)
ETHYL VANILLIN(YC9ST449YJ)
FD&C RED NO. 40(WZB9127XOA)
HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
hydroxypropyl cellulose(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
MALTODEXTRIN(7CVR7L4A2D)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(461P5CJN6T)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS(SX01TZO3QZ)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE(B70850QPHR)
SUCROSE(C151H8M554)
TRIBASIC SODIUM PHOSPHATE(A752Q30A6X)
VANILLIN(CHI530446X)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Azithromycin, unspecified form