Certificate of Analysis

Certificate Number 00071549

LEO Pharma
LEO Laboratories Ltd. Item Description: FUCIDIN® OINT 2 % 5 G ID/TUNGGAL IDAMAN
Cashel Road, Crumlin Pack Lot Number: A89466
Dublin 12, Ireland Market: INDONESIA

Bulk Lot Number: A88684

Manufacture Date: 11 2018
Expiry Date: 11 2021

Test Limit Result

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Appearance To description Conforms

Translucent yellowish to white ointment
Identification of fusidic acid (HPLC) Positive Conforms
Identification of fusidic acid (TLC)* Positive Conforms
ID of sodium by flame colouring* Positive Conforms
Assay of sodium fusidate 19,0 - 21,0 mg/g 20,0
Organic impurities of sodium fusidate:
Total <= 2,0 % 0,1
24,25-dihydro-24,25-dihydroxyfusidic
acid, impurity A (PF673) <= 0,2 % 0,0
24,25-dihydro-24,25-dihydroxyfusidic acid
21,25-lactone, impurity B (SV1423) <= 0,3 % 0,0
(24R)-24,25-dihydro-24,25- dihydroxyfusidic
acid 21,24-lactone, impurity C (SV1424) <= 0,3 % 0,0
(24S)-24,25-dihydro-24,25-dihydroxyfusidic
acid 21,24-lactone, impurity D (SV1425) <= 0,3 % 0,0
26-oxofusidic acid, impurity F (SV1086) <= 0,3 % 0,0
3-didehydrofusidic acid,
impurity G (VD524) <= 0,5 % 0,1
Single, unspecified <= 0,2 % 0,1
Particle size >= 90 %<= 25 µm Conforms
Microbiological quality (CYC) Ph.Eur. 5.1.4 Conforms
Preparations for Cutaneous use

Comments: * Test applies at release only.

(CYC) = Test for named micro-organisms (Ph.Eur.2.6.13) performed on
one in every ten batches at release.

It is hereby certified that the above information is authentic and accurate.

This batch of product has been manufactured, including packaging and quality control
at the above mentioned site in full compliance with 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 were reviewed
and found to be in compliance with GMP.

12/DEC/2018 Released by electronic signature. page 1 of 2

 Certificate of Analysis

Certificate Number 00071549

LEO Pharma
LEO Laboratories Ltd. Item Description: FUCIDIN® OINT 2 % 5 G ID/TUNGGAL IDAMAN
Cashel Road, Crumlin Pack Lot Number: A89466
Dublin 12, Ireland Market: INDONESIA

LOT RELEASE:

Manufactured. . . . . . . . : 11 2018
Expiry. . . . . . . . . . . : 11 2021
Batch size. . . . . . . . . : 2,000 KG
Pack size. . . . . . . . . .: Tube 5 g
Quantity released. . . . . .: 15000 Packs
Date of testing. . . . . . .: 07-12-2018

It is hereby certified that the above information is authentic and accurate.

This batch of product has been manufactured, including packaging and quality control
at the above mentioned site in full compliance with 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 were reviewed
and found to be in compliance with GMP.

All Starting materials, packing materials and final product were tested in
accordance with valid testing procedures and comply with the approved
specifications of the Marketing Authorisation.
The production and in-process controls were performed according to current
approved production requirements. Production facilities are routinely monitored
and LEO Pharma IE is inspected regularly by the Regulatory body " The health
Products Regulatory Authority" (HPRA).

12/DEC/2018 Released by electronic signature. page 2 of 2