Certificate of Compliance

KRKA, d.d., Novo mesto

Date: 19.05.2015
Page: 1/2

Name of Product: 756860

CIPRINOL 500 mg film coated tablets

Dosage form: Film coated tablets (pcs)

Strenght/Potency (ammount per unit dose): 500mg
Batch No. final product: NB8270
Batch No. bulk: NB6174
Date of manufacture: 02.2015
Importing country - Marketing Authorisation No.:
RO - 5921/2005/01

Package size: 10

Name and address of manufacturing site for bulk:

KRKA, d.d., Novo mesto
marjeka cesta 6, 8501
Novo mesto, Slovenia

Manufacturing Authorisation No:

800-24/2014-13

Name and address of manufacturing site for finished product:

KRKA, d.d., Novo mesto
marjeka cesta 6, 8501
Novo mesto, Slovenia

Manufacturing Authorisation No:

800-24/2014-13

Name and address of quality control:

KRKA, d.d., Novo mesto
marjeka cesta 6, 8501
Novo mesto, Slovenia

Manufacturing Authorisation No:

800-19/2013-5

Quantity of Batch: 83.492 PC

Acording to Specification: SRA0346

Delivered quantity: 1 PC

Customer's batch No.:

Expiry date: 02.2020

Certificate of GMP compliance:

450-2/2014-2

Certificate of GMP compliance:

450-2/2014-2

Certificate of GMP compliance:

450-2/2014-2

Certification statement:
I hereby certify that the above information is authentic and accurate. This batch of product has been manufactured,
including packaging/labelling and quality control at the above mentioned site(s) in full compliance with the GMP
requirements of the local Regulatory Authority and with the specifications in the Marketing Authorisation of the importing
country. The batch processing, packaging and analysis records where reviewed and found to be in compliance with
GMP.
Date of release:
11.05.2015

Qualified Person for Batch Release:

Majda enica
Quality Management Division
KRKA, d.d. Novo mesto,
marjeka cesta 6,
8501 Novo mesto, Slovenia

__________________________________________________________________________
This Certificate of Analysis is signed electronicaly.
It has been created automatically by the validated SAP.

Certificate of Analysis

KRKA, d.d., Novo mesto

Date: 19.05.2015
Page: 2/2

Name of Product: 756860

CIPRINOL 500 mg film coated tablets

Dosage form: Film coated tablets (pcs)

Strenght/Potency (ammount per unit dose): 500mg
Batch No. final product: NB8270
Batch No. bulk: NB6174
Date of manufacture: 02.2015

Package size: 10
Customer's batch No.:
Expiry date: 02.2020

___________________________________________________________________________
Characteristic
Specification
Results
___________________________________________________________________________
Appearance

Complies
Oval, white, one side scored film-coated
tablets.
Uniformity of mass
Complies
Not more than 2 of 20 tablet masses deviate
from average mass by more than +- 5% and none
deviates by more than +- 10%
Identification of ciprofloxacin - HPLC
Complies
Assay is the same time identification.
Water (K.F.)
4.5 - 9.0 %
5.9
Related substances - fluoroquinolonic acid
Max. 0.2 %
<= 0.2
Related substances - total
Max. 1.0 %
0.2
Rel.substances-ethylenediamine analog
Max. 0.4 %
0.1
Related substances - other individual
Max. 0.2 %
0.1
Content of ciprofloxacin
95.0 - 105.0 % of stated amount
100.3
Dissolution of ciprofloxacin
Min. 85 % of st.am.in 30 min
98 -103
Microbiological quality - TAMC
Max. 1000 CFU/g
*1
Microbiological quality - TYMC
Max. 100 CFU/g
*1
Microbiological quality - Escherichia coli
*1
Absent in 1 g
__________________________________________________________________________

Date of release:
11.05.2015

Qualified Person for Batch Release:

Majda enica
Quality Management Division
KRKA, d.d. Novo mesto,
marjeka cesta 6,
8501 Novo mesto, Slovenia

*1 Testing not performed on every batch (monitoring programe- at least one batch per year).

__________________________________________________________________________
This Certificate of Analysis is signed electronicaly.
It has been created automatically by the validated SAP.