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Azythromycin

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ACTIVE PHARMA INGREDIENTS

79 API Suppliers, 25 USDMF, 8 CEP/COS, 8 JDMF, 5 EU WC, 12 KDMF, 3 NDC API, 44 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

105 Drugs in Development

105 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

557 FDF Dossiers, 86 FDA Orange Book, 155 Europe, 12 Canada, 30 Australia, 28 South Africa, 246 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- EQ 250MG BASE, TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL, TABLET;ORAL - EQ 500MG BASE, FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM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 Rheology Modifiers, 8 Emulsifying Agents, 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

89 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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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
29/11/2025	TAPI Technology & API Services	Israel	TAPI NL BV	15261	AZITHROMYCIN MONOHYDRATE	2001-01-24	Active	II	N/A
12/12/2025	Lupin Manufacturing Solutions	India	LUPIN MANUFACTURING SOLUTIONS LTD	25820	AZITHROMYCIN MONOHYDRATE USP (PROCESS B)	2012-04-02	Active	II	Complete	2013-08-23	2013-01-04

Azythromycin

Azythromycin

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

79 API Suppliers

25 USDMF

8 CEP/COS

8 JDMF

5 EU WC

12 KDMF

3 NDC API

44 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

105 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

557 FDF Dossiers

86 FDA Orange Book

155 Europe

12 Canada

30 Australia

28 South Africa

246 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

TABLET;ORAL - EQ 600MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons