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Prograf Certification
Certification of Compliance with Consumer Product Safety Improvement Act of 2008
 
1. Product
Prograf capsules – 0.5 mg – 100 count
  Prograf capsules – 1 mg – 100 count
  Prograf capsules – 5 mg – 100 count
   
2. Applicable Regulation
  16 CFR 1700.14(a)(10)
   
3. Manufacturer
  Astellas Toyama Co., Ltd.
  2–178 Kojin–machi, Toyama
  930–0809, Japan
  Telephone +81 (76) 431–3951
   
4. U.S. Importer
  Astellas Pharma Manufacturing, Inc
  3125 Staley Road
  Grand Island, NY 14072
  Telephone (716) 775–2200
   
5. Contact Information
  Senior Director, Corporate QA
  Astellas Toyama Co., Ltd.
  2–178 Kojin–machi, Toyama
  930–0809, Japan
  Telephone +81 (76) 431–3951
   
6. Date and Location of Product Manufacture
 
All product(s) listed in Section 1 of this certification have an expiration date in the following format – Month/Year. Date of Manufacture can be determined by subtracting 35 months from the Expiration Date listed on the product labeling. These products are manufactured at:
 
  Astellas Toyama Co., Ltd.
  2–178 Kojin–machi, Toyama
  930–0809, Japan
  Telephone +81 (76) 431–3951
   
7. Date and Location of Compliance Testing
  April 16, 1998 – Jarfalla, Sweden
   
8. Third–party Laboratory Certifying Compliance
  Ergonomi Institutet AB
  Ringarvagen 7
  S–175 79 Jarfalla, Sweden
  Telephone +46 (8) 760–1800
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