Hi

Is there a source which provides the details of FDA inspected/approved manufacturing facilities. There are apparently more than 100 FDA approved facilities in India. I would like to know their names? Can someone help me on this.

Thanks
John

Hi

Is there a source which provides the details of FDA inspected/approved manufacturing facilities. There are apparently more than 100 FDA approved facilities in India. I would like to know their names? Can someone help me on this.

Thanks
John

Hi John,

Firstly welcome to the Cove :bigwave:

For the list of FDA approved manufacturing facilities for medical devices, go to the CDRH - Registration and Listing Database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm) and enter INDIA under "Establishment Country".

You could further filter using "Establishment Type" to get specific data. :)

Hi Ajit

Thanks very much for that.:)

I was actually looking for drug manufacturers' list. Is there a similar database for that??

Would be really helpful.

Thanks

Hi Ajit

Thanks very much for that.:)

I was actually looking for drug manufacturers' list. Is there a similar database for that??

Would be really helpful.

Thanks

Oh :mg:

I am not sure for drug manufacturers registration database. Btw, are you looking for API manufacturers or Formulations manufacturers ?

Oh :mg:

I am not sure for drug manufacturers registration database. Btw, are you looking for API manufacturers or Formulations manufacturers ?

Oh.

I'm looking for formulation manufacturers in India (preferrably). API manufacturers would be nice-to-have!!

Can you tell me where FDA publishes news - if it has approved/inspected a manufacturing facility? Probably I can find out from there?

Thanks

Take a look at the Drug Applications Site Map (http://www.fda.gov/cder/regulatory/applications/apps-sitemap.htm)

You could also browse through the Databases on the CDER Website (http://www.fda.gov/cder/cder_db_description.htm#registration)

Hi

Is there a source which provides the details of FDA inspected/approved manufacturing facilities. There are apparently more than 100 FDA approved facilities in India. I would like to know their names? Can someone help me on this.

Thanks
John

Did you find an answer to your question? I am also interested in a list of FDA approved manufacturing facilities. Although in my case I am interested specifically in FDA approved biologics API contract manufacturing organisation worldwide. Any info would be useful, thanks.:applause: