DMF fee is applicable only for type II DMFs  (API or Drug  Substance).  There is no fee charged by FDA for packing material or excipient DMF. FY 2019 , DMF fee is     $ 55,013.   This fee should be paid well before referencing your DMF in your ANDA application. However, you can still submit the… Read More

Pragmatic offers a complete solution for all types of DMF submission to the FDA. We offer DMF review, compilation, technical gap analysis, eCTD conversion and submission through ESG. We also provide services for management throughout the lifecycle of a drug master file. Please contact us for more information.

A Drug Master File – or DMF – is FDA’s provision to submit confidentiality information on the chemistry, manufacturing and control information about a product for the agency’s evaluation.

You should self identify if you are performing generic drug-related activities, including manufacturing, testing, or clinical studies.  It is more important to know when you should self identify. Our services can save you time and money.

With our support, the self-identification process takes about 48 hours.

The FDA publishes a list of all self-identified facility addresses, along with their type of business.

Only facilities that manufacture, or intend to manufacture, generic drug APIs, FDFs, or both, are required to pay facility fees. Sites and organizations that only perform testing, repackaging, or re-labelling are not required to pay a user fee.

All facilities involved in generic drug manufacturing (including API manufacturing), packing, testing and bio-equivalence testing are required to self-identify.

Our fees for drug listing are $250.

Our fees for NDC number assistance are $199.

For drug listing, we need the following information: Product label Labelling information Packaging configuration FEI number

Drug listing is the process of providing product and labeling information to FDA in electronic format.

Establishments must renew their registration annually, between October 1st and December 31st of each year.

We prepare the establishment registration SPL on behalf of your company and submit to the FDA through our ESG gateway. We also provide US Agent services for non-US companies.

The FDA does not charge any fee for Establishment Registration. See our pricing section for consulting fees.

Generally, it takes two to three working days.

The contact address and DUNS number are required for Establishment Registration. Non US-companies are also required to provide US Agent information. If required, we can act as US agent for your company.

As per 21 CFR 207, domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA.

If all the submitted information is appropriate and correct, the process takes between 12 and 16 months. If you have any other questions about ANDA, please feel to contact us.

Generally, ANDA includes chemistry, manufacturing, control, bio study and administrative information.

A generic drug is identical–or bio equivalent–to a brand name drug (already approved by FDA) in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.

Any companies interested in obtaining generic drug approval should file ANDA.

ANDA is the Abbreviated New Drug Application, the FDA’s generic drug approval process.