We make legally safe Orthopedic Implants in India for global requirement
 
 
Certifications
 
 
It is a matter of pride & pleasure for SHPOPL to announce grant of Drugs Manufacturing licence in the form 28 by Central Licence approving Authority, New delhi for our entire Orthopedic implant range. SHPOPL was the first Indian manufacturer to comply with application formalities to the newly introduced FDA manufacturing License in 2006 in view of Central Government gazette notification no. GSR 627 (E) dated 7th October 2005. The following links will display respective files in Pdf format.
 
 
 
SHPOPL has been awarded ISO 9001-2008 quality system from year 2000 and has been certified for ISO-13485 & CE certification in year 2004.
 
 
 
  ISO 13485:2003 ISO 9001:2008 / ISO 13485:2003 CE 0434
       
 
       
       
  FDA Licence Annexure-page  
       
   
 
 
 
Gazette Notification
 
Public notice by FDA
 
Awareness campaign
 
 
 
 
 
 
 
 
       
 
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S.H.Pitkar Orthotools Pvt.Ltd. India
Pitkar Orthotools Pvt.Ltd.