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Unimax is exhibiting at CPHI Barcelona 2023 (Hall 6 , Booth Number - IP39). Unimax has received CEP Registration Number 2023-189 for API 'Erythromycin Base'

API Product List

Products

Therapeutic Category

CAS Number

Pharmacopoeia

DMF ( Open and Closed Part available)

Available Status

Country Specific Registration details

WHO GMP

EUWC

CEP

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

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

Erythromycin Phosphate

Antibacterial

4501-00-2

In-House specification

Erythromycin Lactobionate (Oral Grade)

Antibacterial

3847-29-8

BP/EP

Erythromycin 11-12 cyclic carbonate

Antibacterial

55224-05-0

In-House specification

Azithromycin Dihydrate

Macrolide Antibacterial

117772-70-0

IP/BP/EP/USP

Yes

Yes

Yes

#

Russia : RU Number & Date –    C-000701 DT 04.09.13
Iran:Registration Number- 44171/459

Azithromycin Anhydrous / Base

Macrolide Antibacterial

83905-01-5

USP

Azithromycin Monohydrate

Macrolide Antibacterial

121470-24-4

USP

Azithromycin Dihydrate (Taste masked Powder)

Macrolide Antibacterial

USP

Azithromycin premix for suspension

Macrolide Antibacterial

In-House Specification

Clarithromycin Powder

Macrolide Antibacterial

81103-11-9

IP/BP/USP

Roxithromycin

Macrolide Antibacterial

80214-83-1

BP/EP/USP

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