sandeep reddy
☆    

India,
2013-06-27 16:06
(4750 d 14:15 ago)

Posting: # 10892
Views: 3,092
 

 BE Noc [Regulatives / Guidelines]

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Dear all

Can anyone clarify my doubt regarding the BE NOC of carbidopa 25mg tablets. fixed dose combination of carbidopa and levodopa is approved in India but not carbidopa alone is it neccesary to go for BE NOC.


sandeep reddy
research associate (PK and medical writing)
 
raghu
★    

India,
2013-06-28 10:09
(4749 d 20:12 ago)

@ sandeep reddy
Posting: # 10894
Views: 2,511
 

 BE Noc

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❝ Can anyone clarify my doubt regarding the BE NOC of carbidopa 25mg tablets. fixed dose combination of carbidopa and levodopa is approved in India but not carbidopa alone is it neccesary to go for BE NOC.


Yes, You have to go for BE NOC.

Raghu
 
drgunasakaran1
★★  
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2013-06-28 10:52
(4749 d 19:30 ago)

@ sandeep reddy
Posting: # 10896
Views: 2,455
 

 BE Noc

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Dear Mr Sandeep Reddy,

Carbidopa is an Old Drug. It has been approved and marketed in India for more than 04 years. Hence, there is no need BE NOC approval for Carbidopa tablets.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
 
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