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

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Product

Azithromycin
CAS 76801-85-9
Azithromycin Dihydrate
Azathramycin
USDMF

Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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Gensenta is a trusted CDMO partner with robust history, commitment to quality, innovative mindset and commitment to sustainability.

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Azithromycin

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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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

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

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

6 API Suppliers

6 API Suppliers

FINISHED DOSAGE FORMULATIONS

562 FDF Dossiers, 86 FDA Orange Book, 208 Europe, 13 Canada, 28 Australia, 27 South Africa, 200 Listed Dossiers

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- EQ 250MG BASE, TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL, TABLET;ORAL - EQ 500MG BASE, FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM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

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TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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

11 DATA COMPILATION #PharmaFlow
96 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

1 US Medicaid Prescriptions
208 Finished Drug Prices
10 Annual Reports

MARKET PLACE

79 APIs, 38 FDF Dossiers, 1 Intermediates

79 APIs
38 FDF Dossiers
1 Intermediates

PATENTS & EXCLUSIVITIES

2 US Patents, 3 Health Canada Patents

2 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 8 USP, 9 Others

4 EDQM
8 USP
9 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 189 Xls

Filters

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26 All

01 1Taro Pharmaceutical Industries

02 3Alembic Pharmaceuticals Limited

03 2CSPC Pharmaceutical Group

04 1Calyx Chemicals & Pharmaceuticals Limited

05 2HEC Pharm

06 1Hainan Poly Pharm

07 1ITF CHEMICAL LTDA

08 1Jubilant Generics

09 2Lupin Ltd

10 1Mahima Life Sciences

11 1PJ healthcare

12 1Quimica Sintetica

13 1Sandoz B2B

14 1Sterile India Pvt. Ltd

15 3Teva API

16 3Wockhardt

17 1Zhejiang Guobang Pharmaceutical

filter Subject Reset all filters

26 All

01 1ANHYDROUS AZITHROMYCIN

02 1AZITHROMYCIN

03 1AZITHROMYCIN (LYOPHILIZED BULK STERILE)

04 1AZITHROMYCIN GRANULES FOR ORAL SUSPENSION

05 1AZITHROMYCIN HYDROGENCITRATE

06 1AZITHROMYCIN MONHYDRATE, NON-STERILE BULK DRUG SUBSTANCE

07 6AZITHROMYCIN MONOHYDRATE

08 1AZITHROMYCIN MONOHYDRATE (NON-STERILE BULK)

09 1AZITHROMYCIN MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE

10 4AZITHROMYCIN MONOHYDRATE USP

11 1AZITHROMYCIN MONOHYDRATE USP (PROCESS B)

12 1AZITHROMYCIN MONOHYDRATE USP (PROCESS-II)

13 1AZITHROMYCIN N

14 1AZITHROMYCIN TASTE MASKING GRANULES 7.5%

15 1AZITHROMYCIN USP

16 1AZITHROMYCIN USP (API)

17 1AZITHROMYCIN USP (DIHYDRATE)

18 1AZITHROMYCIN-FORM I

filter Country Reset all filters

26 All

01 1Brazil

02 6China

03 13India

04 3Israel

05 1Spain

06 1Switzerland

07 1U.S.A

filter Status Reset all filters

26 All

01 13Active

02 13Inactive

filter GDUFA DMF Review Reset all filters

26 All

01 7Complete

02 19Blank

API Suppliers
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JDMF
EU WC
KDMF
NDC API
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Product Main Page

01

Taro Pharmaceutical Industries Ltd

FNCE 2024

Not Confirmed

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Digital Content

Azithromycin Monohydrate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2015-06-29

Pay. Date : 2015-03-02

DMF Number : 28294

Submission : 2015-03-02

Status : Active

Type : II