Products |
Therapeutic Category |
CAS Number |
Pharmacopoeia |
DMF ( Open and Closed Part available) |
Available Status |
Country Specific Registration details |
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WHO GMP |
EUWC |
CEP |
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Erythromycin Base |
Antibacterial |
114-07-08 |
IP/BP/EP/USP/JP |
Yes |
Yes |
Yes |
# |
Russia : RU Number & Date : JICP-002482/10 |
Erythromycin (High Purity for Intermediate Application) |
Antibacterial |
114-07-08 |
In-House Specification |
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US Registration |
Erythromycin Stearate |
Antibacterial |
643-22-1 |
IP/BP/EP/USP |
Yes |
Yes |
Yes |
|
|
Erythromycin Estolate |
Antibacterial |
3521-62-8 |
USP |
Yes |
Yes |
Yes |
|
Taiwan:TFDA Number 1096015392 |
Erythromycin Ethyl Succinate |
Antibacterial |
41342-53-4 |
IP/BP/EP/USP |
Yes |
Yes |
Yes |
# |
Iran : Registration Number – 776 |
Erythromycin Propionate |
Antibacterial |
134-36-1 |
FP |
|
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|
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Erythromycin Phosphate |
Antibacterial |
4501-00-2 |
In-House specification |
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Erythromycin Lactobionate (Oral Grade) |
Antibacterial |
3847-29-8 |
BP/EP |
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Erythromycin 11-12 cyclic carbonate |
Antibacterial |
55224-05-0 |
In-House specification |
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|
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Azithromycin Dihydrate |
Macrolide Antibacterial |
117772-70-0 |
IP/BP/EP/USP |
Yes |
Yes |
Yes |
# |
Russia : RU Number & Date – C-000701 DT 04.09.13 |
Azithromycin Anhydrous / Base |
Macrolide Antibacterial |
83905-01-5 |
USP |
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Azithromycin Monohydrate |
Macrolide Antibacterial |
121470-24-4 |
USP |
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Azithromycin Dihydrate (Taste masked Powder) |
Macrolide Antibacterial |
|
USP |
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Azithromycin premix for suspension |
Macrolide Antibacterial |
|
In-House Specification |
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Clarithromycin Powder |
Macrolide Antibacterial |
81103-11-9 |
IP/BP/USP |
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Roxithromycin |
Macrolide Antibacterial |
80214-83-1 |
BP/EP/USP |
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Products will only be offered to the market where any process or products patents are not infringing. During the validity of the patents the research quantities for developing products for regulatory submission will only be offered to countries where such exemption exists (Hatch waxman Act / Bolar exemption). Recipient are requested to make their evaluation & determination as to the patent status prior to their use of information or materials in their respective jurisdication.
Remarks –
# : Document under preparation
WHO-GMP : Issued by Maharshtra state FDA based on format recommended by WHO
EUWC : European Union Written Confirmation
All Products can be offered as per customer in-house specification