Bayer Brand of Azithromycin Dihydrate

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ACTIVE PHARMA INGREDIENTS

81 API Suppliers, 26 USDMF, 9 CEP/COS, 8 JDMF, 5 EU WC, 12 KDMF, 3 NDC API, 44 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

75 Drugs in Development

75 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

538 FDF Dossiers, 86 FDA Orange Book, 137 Europe, 12 Canada, 33 Australia, 27 South Africa, 243 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- EQ 250MG BASE, TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL, TABLET;ORAL - EQ 500MG BASE, FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM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, 3 Rochem International Inc, 21 SPI Pharma, 7 DKSH, 1 Pharm-RX Chemical, 6 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 5 Kirsch Pharma, 1 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 18 BASF, 2 CD Formulation, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 2 Esteem Industries, 2 Finar, 9 Gangwal Chemicals, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 22 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 1 Lubrizol Life Science Health, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 6 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, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 33 Thickeners and Stabilizers, 32 Disintegrants & Superdisintegrants, 31 Direct Compression, 29 Taste Masking, 28 Controlled & Modified Release, 28 Granulation, 20 Chewable & Orodispersible Aids, 18 Parenteral, 17 Lubricants & Glidants, 17 Solubilizers, 16 Topical, 13 Film Formers & Plasticizers, 12 Co-Processed Excipients, 8 Emulsifying Agents, 8 Rheology Modifiers, 7 API Stability Enhancers, 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

27 US Medicaid Prescriptions, 107 Regulatory FDF Prices, 11 Annual Reports

MARKET PLACE

88 APIs, 38 FDF Dossiers, 1 Intermediates

PATENTS & EXCLUSIVITIES

3 Health Canada Patents

3 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 6 USP, 15 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 50733 / DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE/VIAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AZITHROMYCIN DIHYDRATE(UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)	AZITHROMYCIN ANHYDROUS	100mg in 1

Inactive Ingredients

Ingredient Name	Mylan Institutional LLC	Sagent Pharmaceuticals	APOTEX CORP.	Athenex Pharmaceutical Division, LLC.	Baxter Healthcare Corporation	Cardinal Health	Fresenius Kabi USA, LLC
anhydrous citric acid(XF417D3PSL)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
SODIUM HYDROXIDE(55X04QC32I)

Drug Product Composition: Bayer Brand of Azithromycin Dihydrate