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Approved Drug Products containing Azithromycin Dihydrate listed in the FDA Orange Book. Original Data : FDA Website

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Product

Azithromycin Dihydrate
Azithromycin
FDA Orange Book

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Azithromycin Dihydrate

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ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 11 USDMF, 12 CEP/COS, 2 EU WC, 21 NDC API, 22 Listed Suppliers, $ API Reference Price

37 API Suppliers
11 USDMF
12 CEP/COS
2 EU WC
21 NDC API
22 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports

FINISHED DOSAGE FORMULATIONS

71 FDF Dossiers, 1 FDA Orange Book, 15 Europe, 17 Canada, 14 South Africa, 24 Listed Dossiers

71 FDF Dossiers
1 FDA Orange Book
15 Europe
17 Canada
14 South Africa
24 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 4 SPI Pharma, 5 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 5 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 1 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 7 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 28 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 1 Nanjing Bold Chemical, 1 Novo Excipients, 4 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 4 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 4 Sigachi Industries, 2 The Dow Chemical Company, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 34 Fillers, Diluents & Binders, 18 Controlled & Modified Release, 18 Direct Compression, 16 Granulation, 13 Lubricants & Glidants, 11 Disintegrants & Superdisintegrants, 10 Thickeners and Stabilizers, 8 Film Formers & Plasticizers, 8 Co-Processed Excipients, 7 Taste Masking, 5 Empty Capsules, 5 API Stability Enhancers, 5 Topical, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Solubilizers, 4 Emulsifying Agents, 4 Rheology Modifiers, 3 Parenteral, 1 Surfactant & Foaming Agents

45 Coating Systems & Additives
34 Fillers, Diluents & Binders
18 Controlled & Modified Release
18 Direct Compression
16 Granulation
13 Lubricants & Glidants
11 Disintegrants & Superdisintegrants
10 Thickeners and Stabilizers
8 Film Formers & Plasticizers
8 Co-Processed Excipients
7 Taste Masking
5 Empty Capsules
5 API Stability Enhancers
5 Topical
4 Chewable & Orodispersible Aids
4 Vegetarian Capsules
4 Coloring Agents
4 Solubilizers
4 Emulsifying Agents
4 Rheology Modifiers
3 Parenteral
1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 NEWS #PharmaBuzz

1 NEWS #PharmaBuzz

MARKET PLACE

51 APIs, 1 FDF Dossiers

51 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

27 Health Canada Patents

27 Health Canada Patents

$ API Ref.Price (USD/KG) : 190 Xls

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01 1PFIZER

filter Dosage Reset all filters

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01 1FOR SUSPENSION, TABLET;ORAL

filter Regulatory Info Reset all filters

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01 1DISCN

filter Brand Name Reset all filters

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01 1TROVAN/ZITHROMAX COMPLIANCE PAK

filter RLD Reset all filters

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01 1No

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
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01

PFIZER

FNCE 2024

Not Confirmed

PFIZER

FNCE 2024

Not Confirmed

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Digital Content

RLD : No

TE Code :

AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE

Brand Name : TROVAN/ZITHROMAX COMPLIANCE PAK

Dosage Form : FOR SUSPENSION, TABLET;ORAL

Dosage Strength : EQ 1GM BASE,N/A;N/A,EQ 100MG BASE

Approval Date : 1998-12-18

Application Number : 50762

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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