State the name and street address of each facility where any aspect of manufacture occurs, including production, sterilization, packaging and quality control. Indicate the activity performed at each site.

Include any alternative manufacturers.

For each site where the major production step(s) is/are carried out, attach a certificate issued by the competent authority in terms of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. Include the product information approved by that authority with, if available, the summary basis of approval (or similar) and any other relevant material.