Date:

DECLARATION LETTER

We, Sri Krishna, declare that the methodology and specifications of the microbial testing of
the excipients of the product, RIVAROXABAN TABLETS 15 mg & 20 mg, were performed using
the following criteria:

Excipient Pathogenic microorganisms Specification

Microcrystalline cellulose (PH
101) Escherichia coli Absent/g
Lactose Monohydrate Pseudomonas aeruginosa Absent/g
Croscarmellose Sodium Staphylococcus aureus Absent/g
Hypromellose Salmonella spp. Absent/10g
Sodium laurilsulfate
Magnesium stearate
Escherichia coli Should be absent/100mL

Salmonella spp. Should be absent/100mL

Purified water
Pseudomonas aeruginosa Should be absent/100mL

Staphylacoccus aureus Should be absent/100mL

Kindly consider the above declaration & approve the specification for further process of
registration.

For, Sri Krishna.

Authorized Signatory