SANBE

PT. SANBE FARMA Pharmaceutical Manufacturer

Jl. Taman Sari 10 Bandung 40116 TromolPos 850 Bandung 40008
Telp : 62 - 22 - 4207725 (Hunting)
Fax : 62 - 22 - 4238476
Bandung 40116 - Indonesia

JUSTIFICATION LETTER

Herewith we inform that data of Stability Study SANBE KIDS ® Emulsion 60 mL may use Stability
Study SANBE KIDS® Emulsion 200 mL, because both products have the same formula and
packaging material, only different on filled quantity.

This Information is made as properly set.

Bandung, February 27th 2014

IkhsanRambia, Pharmacist
Authorized Signatory
Temporary Incharge
Head of International Regulatory Affairs
and Quality
SANBE
PT. SANBE FARMA Pharmaceutical Manufacturer
Jl. Taman Sari 10 Bandung 40116 TromolPos 850 Bandung 40008
Telp : 62 - 22 - 4207725 (Hunting)
Fax : 62 - 22 - 4238476
Bandung 40116 - Indonesia

JUSTIFICATION LETTER

Herewith we inform that data of Stability Study SANBE KIDS® Emulsion 120 mL may use Stability
Study SANBE KIDS® Emulsion 200 mL, because both products have the same formula and
packaging material, only different on filled quantity.

This Information is made as properly set.

Bandung, February 27th 2014

IkhsanRambia, Pharmacist
Authorized Signatory
Temporary Incharge
Head of International Regulatory Affairs
and Quality