Services to Ease FDA Regulatory Compliance

FAQ: Drugs

How much is the DMF Fee and when should I pay?

For 2017, the FDA DMF fees  are $51,140. This fee should be paid well before referencing your DMF in your ANDA application. It means you can still submit the DMF to FDA without paying the fees and wait for the  ANDA sponsor.

How much time is required for DMF submission?

The timeline for the DMF submission depends on the availability of technical documents. If you have all the documents – including Batch records, Specification, Method of analysis, In process specification, Raw material specification and testing reports, Impurity profiling, Batch analysis data, and stability study – it will take about 10 working days to compile the … Continue reading How much time is required for DMF submission?

How we can assist for DMF submission to FDA?

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.

What is a Drug Master File?

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.

How Can Pragmatic help you with Self Identification?

We just don’t submit your self identification, we also provide guidance on when to self identify, including whether GDUFA fees are applicable to your facility.  Our complete service includes assistance to get an FEI number and complete the self identification of your facility.

When Should I Self-Identify?

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.

How much time will it take to self-identify my facility?

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

How can I very my self-identification status?

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

What information is required for self-identification?

Basic contact information is required, along with information about the nature of the operations – for example, FDF manufacturing or API manufacturing testing.

What about fees for self-identification?

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.

Who needs to self-identify?

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

What are your fees for drug listing?

Our fees for drug listing are $250.

What are your fees for NDC assistance ?

Our fees for NDC number assistance are $199.

What information do I have to provide for Drug Listing?

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

How can you help me with Drug Listing?

We provide a complete service for drug listing and NDC numbers. We will support you through each stage of the process, until your registration is complete.

How much time will Drug Listing take?

Once we have the information, the process takes two to three days.

How much time does it take to obtain the NDC number?

This process takes around 48 hours.

Who needs a Drug Listing?

The owner or operator of an establishment entering into drug manufacture or preparation.

What Is the NDC Number?

The NDC number is 10 digit number, consisting of five labeller-code digits, three product digits and two of package code digits. The product code and package code can be any assigned by the manufacturer/ labeller.

What is a Drug Listing?

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

What is the Labeler Code?

This is the number assigned by the FDA to the manufacturer /packer/labeler of the drug.

When do we need to renew Drug Establishment Registration?

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

How can Pragmatic help with Establishment Registration?

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.

What are the fees for Establishment Registration?

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

How long will it take for Establishment Registration?

Generally, it takes two to three working days.

Does the FDA issue Certificates of Registration?

No. The FDA does not issue any certificates. You can verify your company registration at the below link: http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm

What information is required for Establishment Registration?

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.

Who should register?

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.

What is the time frame for approval for ANDA Applications?

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.

What are the ANDA fees?

For FY2017, the ANDA fee is $70,480.

What information should be included for ANDA?

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

What is a generic drug?

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.

Who should file ANDA?

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

What is ANDA?

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

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