Due to many inquiries about DMF issue, we put the detailed info here.


About Drug Master File (DMF)

About DMF filing in EU (called EDMF), it is different to DMF filing in FDA.

FDA accept DMF file and give a DMF number. Though it does not mean FDA approval or not approval. This DMF file has 2 parts – An open part and the confidential part.

When a finished product manufacturer apply license from FDA, the API supplier/DMF holder will provide an Authority letter to FDA to allow the manufacturer access their entire DMF file.


EU Authority (EMEA) does not give DMF number.

If the API is in Eu. Pharmacopoeia,  EMEA can accept EDMF filing and  issue a “Certificate of Suitability” for it.

If the API is not in Eu. P. EMEA would not accept DMF filing alone. – Paclitaxel is not in Eu. P yet.

So if you apply for Marketing Authorization in EU countries, you need to reach agreement with the API supplier to provide you the entire DMF file (which is technological confidential property of the API factory). So you can including its content into your Marketing Authorization application dossier to submit to EU authority (either your country’s Authority or EU Authority).

Since July 2003, the EDMF file has to be in CTD format. -n  Common Technical Document (CTD) .

Because the confidential nature of the entire DMF file, the API supplier would not give it to any client but only the large quantity long term clients. Also a confidential agreement has to be signed to protect it.

Now you understand no any API supplier can give you the entire DMF file for small quantity order. Normal requirement is over kg PX order. In consider of medical devices manufacturers may need less PX , we set up the lowest threshold level as 100gm PX. This is the lowest level we can go.

The Paclitaxel API supply/DMF (CTD format) contract draft is available.

K regards
21CEC Head Office


21CEC & 21CEP (UK & USA)
21CEC PX Pharm Ltd (UK)

Archer House, Britland Estate,  Northbourne Road, Eastbourne, East Sussex BN22  8PW, UK
London Office: 
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US Office:
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Tel: (44) 0207 9276859 (UK) & Toll-Free (1) 888 2703429 (USA) &  (44)  07732 971307 (CEO Direct line)  

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E mail: office@21cecpharm.com   

URL: www.21cec.com/,    www.21cecPharm.com/  (USA)