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Azithromycin, unspecified form

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ACTIVE PHARMA INGREDIENTS

68 API Suppliers, 26 USDMF, 9 CEP/COS, 8 JDMF, 9 EU WC, 12 KDMF, 2 NDC API, 39 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

21 Drugs in Development

21 Drugs in Development

INTERMEDIATES

6 API Suppliers

6 API Suppliers

FINISHED DOSAGE FORMULATIONS

560 FDF Dossiers, 86 FDA Orange Book, 208 Europe, 13 Canada, 28 Australia, 27 South Africa, 198 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- EQ 250MG BASE, TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL, TABLET;ORAL - EQ 500MG BASE, FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM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

1 Evonik, 4 Rochem International Inc, 20 SPI Pharma, 2 Seqens, 5 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 12 Gangwal Healthcare, 5 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

EXCIPIENTS BY APPLICATIONS

79 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 39 Direct Compression, 33 Controlled & Modified Release, 30 Disintegrants & Superdisintegrants, 29 Thickeners and Stabilizers, 25 Granulation, 24 Taste Masking, 18 Chewable & Orodispersible Aids, 18 Lubricants & Glidants, 17 Parenteral, 16 Co-Processed Excipients, 15 Solubilizers, 15 Topical, 11 Film Formers & Plasticizers, 8 API Stability Enhancers, 7 Emulsifying Agents, 5 Empty Capsules, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Coloring Agents, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

11 DATA COMPILATION #PharmaFlow, 96 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

MARKET PLACE

79 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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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
26/09/2024	Taro Pharmaceutical Industries	U.S.A	TARO PHARMACEUTICAL INDUSTRIES LTD	28294	AZITHROMYCIN MONOHYDRATE USP	2015-03-02	Active	II	Complete	2015-06-29	2015-03-02
26/09/2024	Alembic Pharmaceuticals Limited	India	ALEMBIC PHARMACEUTICALS LTD	24754	AZITHROMYCIN MONOHYDRATE USP (PROCESS-II)	2011-02-01	Active	II	Complete	2014-01-06	2013-09-26

List of Drug Master Files (DMF) of Azithromycin, unspecified form Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Azithromycin, Unspecified Form

Azithromycin, unspecified form

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

68 API Suppliers

26 USDMF

9 CEP/COS

8 JDMF

9 EU WC

12 KDMF

2 NDC API

39 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

21 Drugs in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

6 API Suppliers

FINISHED DOSAGE FORMULATIONS

560 FDF Dossiers

86 FDA Orange Book

208 Europe

13 Canada

28 Australia

27 South Africa

198 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

1 Evonik

4 Rochem International Inc

20 SPI Pharma

2 Seqens

5 DKSH

1 Jai Radhe Sales

1 Pharm-RX Chemical

12 Gangwal Healthcare

5 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

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