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Cover Letter

Eurolife Healthcare Pvt. Ltd. is submitting an application for registration of their finished pharmaceutical product GLUCOLIFE, an intravenous infusion of glucose at a 5% concentration in 500ml bottles. The application includes a CD with a Quality Overall Summary and Bioequivalence Trial Information in word format and body data in pdf format. Eurolife confirms that future submissions for this product will be in the same format and that the electronic submission has been checked for viruses.

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466 views1 page

Cover Letter

Eurolife Healthcare Pvt. Ltd. is submitting an application for registration of their finished pharmaceutical product GLUCOLIFE, an intravenous infusion of glucose at a 5% concentration in 500ml bottles. The application includes a CD with a Quality Overall Summary and Bioequivalence Trial Information in word format and body data in pdf format. Eurolife confirms that future submissions for this product will be in the same format and that the electronic submission has been checked for viruses.

Uploaded by

nimishaaaa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

COVER LETTER

APPLICATION FOR DRUG REGISTRATION

Ref: ................................................
Applicant: Eurolife Healthcare Pvt. Ltd. India
Address: Plot No. B-15/2, MIDC Industrial Area, Waluj, Aurangabad-431136, INDIA
Post code: 431136 Town: Aurangabad, Maharashtra Country: INDIA
Date:
Reference:
The Secretary to the Authority,
National Drug Authority, Plot 19 Lumumba Avenue
P.O. Box 23096, Kampala, UGANDA
Phone: (+256) 41-255665 / 347391/ 347392
Fax: (+256) 41-255758
E-mail: ndaug@[Link]
Subject: Submission of Application(s) for Marketing Authorization of GLUCOLIFE - (GLUCOSE
INTRAVENOUS INFUSION BP (5%w/v) 500 ML

Dear Sir,
We are pleased to submit our Application(s) for a registration of finished pharmaceutical product(s)
whose details are as follows:
Name of the finished pharmaceutical product(s): GLUCOLIFE - (GLUCOSE INTRAVENOUS
INFUSION BP (5%w/v) 500 ML

Pharmaceutical form(s) and strength(s): Intravenous Infusion and (5 % W/V) 500ml

INN/active substance(s): Anhydrous Glucose BP

ATC Code(s): B05BA03

You will find enclosed the submission dossier as specified hereafter:

CD rom; Quality Overall Summary and Bioequivalence Trial Information in word


format and body data in pdf format.
We confirm that all future submissions for this specific product will be submitted in
this same format.
We confirm that the electronic submission has been checked with an up-to-date and
state-of- the-art virus checker.

The relevant fees have been paid.

Yours sincerely,
Signature:

Name: Purva Arsekar


Title: Executive- Regulatory Affairs
Phone number: +22 42374211
Email address: purvaarsekar@[Link]

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