Pfizer CentreOne CPhI Barcelona

Pfizer CentreOne CPhI Barcelona

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List of Drug Master Files (DMF) of Azithromycin Active Pharmaceutical Ingredient listed on PharmaCompass.com

Product

Azithromycin

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

65 API Suppliers, 26 USDMF, 8 CEP/COS, 8 JDMF, 11 EU WC, 13 KDMF, 2 NDC API, 35 Listed Suppliers

DEVELOPMENTS

20 Drug(s) in Development

20 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

INTERMEDIATES

5 Suppliers

5 Suppliers

DOSSIERs // Finished Dosage Formulations

482 Dossiers, 86 FDA Orange Book, 167 Europe, 15 Canada, 25 Australia, 27 South Africa, 162 Listed Dossiers

DRUG PRODUCT COMPOSITION

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- EQ 250MG BASE, TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL, TABLET;ORAL - EQ 500MG BASE, FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM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, SOLUTION/DROPS;OPHTHALMIC - 1%

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TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
SOLUTION/DROPS;OPHTHALMIC - 1%

RELATED EXCIPIENT COMPANIES

Suppliers, 33 Kerry, 25 Roquette, 18 BASF, 16 SPI Pharma, 13 Actylis, 12 Sigachi Industries, 12 Corel Pharma Chem, 12 Microlex e.U, 11 Gangwal Healthcare, 9 Gangwal Chemicals, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 7 Seppic, 7 Ideal Cures Pvt Ltd, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 6 DFE Pharma, 6 Lonza Capsugel, 5 Ingredion Pharma Solutions, 4 Rochem International Inc, 4 Prachin Chemical, 4 Nanjing Well Pharmaceutical, 4 Vasa Pharmachem, 3 DKSH, 2 Pfanstiehl, 2 Pharmatrans-Sanaq, 2 Nomisma Healthcare, 2 Finar, 2 The Dow Chemical Company, 1 Nanjing Bold Chemical, 1 Kima Chemical, 1 Avesta Pharma, 1 Aeon Procare, 1 Lubrizol Life Science Health, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Jai Radhe Sales, 1 Clariant, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Evonik, 1 ACG Worldwide, 1 Qualicaps

EXCIPIENTS BY APPLICATIONS

78 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 36 Direct Compression, 35 Controlled & Modified Release, 32 Disintegrants & Superdisintegrants, 26 Thickeners and Stabilizers, 24 Taste Masking, 21 Granulation, 17 Chewable & Orodispersible Aids, 17 Lubricants & Glidants, 15 Co-Processed Excipients, 14 Solubilizers, 14 Topical, 13 Parenteral, 10 API Stability Enhancers, 10 Film Formers & Plasticizers, 5 Empty Capsules, 5 Emulsifying Agents, 4 Vegetarian Capsules, 3 Rheology Modifiers, 2 Coloring Agents

GLOBAL SALES INFORMATION

29 US Medicaid Prescriptions, 167 Finished Drug Prices

MARKET PLACE

69 APIs, 38 DOSSIERS // FDF, 1 Intermediates

PATENTS

2 US Patents, 3 Health Canada Patents

ANALYTICAL SOLUTION(s)

2 BioAnalytical Methods, 4 EDQM Standards, 8 USP Standards, 9 Other Ref. Standards

DIGITAL CONTENT

10 Data Compilations & Company Tracker #PharmaFlow, 95 News

List of Suppliers

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ALEMBIC PHARMACEUTICALS LTD

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India

Digital Content

AZITHROMYCIN MONOHYDRATE USP

PDF Supplier PDF

URL Supplier Web Content

DMF Number

18719

Status

Active

Submission Date

2005-08-31

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

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ALEMBIC LTD API DIV

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India

Digital Content

AZITHROMYCIN MONOHYDRATE

PDF Supplier PDF

URL Supplier Web Content

DMF Number

17091

Status

Inactive

Submission Date

2003-12-31

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

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ALEMBIC PHARMACEUTICALS LTD

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India

Digital Content

AZITHROMYCIN MONOHYDRATE USP (PROCESS-II)

PDF Supplier PDF

URL Supplier Web Content

DMF Number

24754

Status

Active

Submission Date

2011-02-01

GDUFA DMF Review

Complete

GDUFA Review Date

2014-01-06

GDUFA Payment Date

2013-09-26

Type

II

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CALYX CHEMICALS AND PHARMACEUTICALS...

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India

Digital Content

AZITHROMYCIN MONOHYDRATE

PDF Supplier PDF

URL Supplier Web Content

DMF Number

27713

Status

Active

Submission Date

2013-09-21

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

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CSPC OUYI PHARMACEUTICAL CO LTD

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China

Digital Content

AZITHROMYCIN

PDF Supplier PDF

URL Supplier Web Content

DMF Number

22331

Status

Active

Submission Date

2008-12-05

GDUFA DMF Review

Complete

GDUFA Review Date

2014-05-16

GDUFA Payment Date

2014-05-07

Type

II

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SHIJIAZHUANG PHARMACEUTICAL GROUP H...

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China

Digital Content

AZITHROMYCIN USP (API)

PDF Supplier PDF

URL Supplier Web Content

DMF Number

20074

Status

Inactive

Submission Date

2006-12-18

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

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HAINAN POLY PHARMACEUTICAL CO LTD

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China

Digital Content

AZITHROMYCIN GRANULES FOR ORAL SUSPENSION

PDF Supplier PDF

URL Supplier Web Content

DMF Number

23486

Status

Inactive

Submission Date

2010-01-27

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

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RUYUAN HEC PHARM CO LTD

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China

Digital Content

AZITHROMYCIN MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE

PDF Supplier PDF

URL Supplier Web Content

DMF Number

28453

Status

Active

Submission Date

2014-10-23

GDUFA DMF Review

Complete

GDUFA Review Date

2015-06-16

GDUFA Payment Date

2015-03-13

Type

II

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HEC PHARM CO LTD

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China

Digital Content

AZITHROMYCIN MONHYDRATE, NON-STERILE BULK DRUG SUBSTANCE

PDF Supplier PDF

URL Supplier Web Content

DMF Number

20852

Status

Inactive

Submission Date

2007-09-10

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

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ITF CHEMICAL LTDA

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Brazil

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