Common deficiencies found by USFDA in DMFs

Earlier Global API market was mainly dominated by Italy & Spain but now situation has been changed because of the emergence of Indian & Chinese generic companies. These companies are giving very tough competition to regularly increase their market share from the share of Italy & Spain. In the fast growing generic market the companies dealing in API have also geared up themselves to tap the huge opportunity of generic API market by developing & filing DMF for no. of APIs, off those patents are to going to expire. Market reports suggests us with in few years India will be at second position in API market.
Due to current FDA regulation DMF filing is not a regulation to sell an API however It becomes a basic requirement of a supply agreement between an API manufacturer and ANDA applicant due to following reasons.
1)As per the import procedure of US and few other countries DMF is required to supply bulk material (API) to the US & other markets.
2)API manufacturers who have large number of DMFs tend to be more dependable in terms of quality, regulatory requirement, and ability to meet cGMP guidelines.
So all the manufacturers are filing DMFs to register their API but only few manufactures are able to utilize their DMFs efficiently because most of the time they got stuck in DMF deficiencies, customer queries, and failed to manage a number of obligations due to these deficiencies. This may also lead to pending and inactive status of their DMF.
I had found most of manufactures were not able to manage the following functions properly, those are very important for the DMF filing and their maintenance.
1)Quality DMF Submission
2)Management of DMF deficiencies & Customer queries
3)Management of DMF Holder’s obligation and other function
In this way at last I found that DMF management system is a good concept
by which a manufacturer can improve a lot in managing their all these important functions which were critical for the success of DMF filing.