Azithromycin

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ACTIVE PHARMA INGREDIENTS

82 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

539 FDF Dossiers, 86 FDA Orange Book, 137 Europe, 12 Canada, 33 Australia, 27 South Africa, 244 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- EQ 250MG BASE, TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL, TABLET;ORAL - EQ 500MG BASE, FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM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 Granulation, 28 Controlled & Modified Release, 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 - 50797 / DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM BASE/BOT

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AZITHROMYCIN DIHYDRATE(UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)	AZITHROMYCIN ANHYDROUS	2g in 60

Inactive Ingredients

Ingredient Name	Pfizer Laboratories Div Pfizer Inc
GLYCERYL DIBEHENATE(R8WTH25YS2)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
MAGNESIUM HYDROXIDE(NBZ3QY004S)
POLOXAMER 407(TUF2IVW3M2)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS(SX01TZO3QZ)
SUCROSE(C151H8M554)
TITANIUM DIOXIDE(15FIX9V2JP)
XANTHAN GUM(TTV12P4NEE)

Setid 1daf9566 168f 4e05 B23e Fdcb09183171 Applno 50797 Form For Suspension Extended Release Oral Dosage Eq 2gm Base Bot - Drug Product Composition: Azithromycin

Azithromycin

Azithromycin

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

82 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

INTERMEDIATES

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

539 FDF Dossiers

86 FDA Orange Book

137 Europe

12 Canada

33 Australia

27 South Africa

244 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

TABLET;ORAL - EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons