Respen-A™ requires a prescription and is currently only available as a compounded prescription medication from the following pharmacies:

Hopewell Pharmacy
1 West Broad Street
Hopewell, NJ 08525
1-800-792-6670

Key Compounding Pharmacy
530 South 336th Street
Federal Way, WA 98003
Toll Free 1-800-878-1322

Wellness Pharmacy
3401 Independence Drive, Ste 231
Birmingham, AL 35209
Toll Free 1-800-227-2627

 

 

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Planned Phase II and III Milestones for Manufacturing

1.C Phase II

Base documentation required to build the process and run packaging and chemical quality control.

1.C.1 Process Build

Item#
Description
Sub-Total (Range)
4.1.1 Mixer, Intensifier
$121,800- $133,980
4.1.2 SS Tank, Insert Blankets, SIP
$60,900- $66,990
4.1.3 GC Testing, establish standard for ID
$14,210- $15,631
4.1.4 Process Water USP plant
$176,610- $194,271
4.1.5 Die Cutter- paste/tablet with mold
$247,660- $272,426
4.1.6 Sheet Dryer
$152,250- $167,475
4.1.7 Stacker
$40,600- $44,660
4.1.8 Packager
$64,960- $71,456
4.1.9 Startup Product – (waste)
$12,180- $13,398

All equipment needed has been broken out above. Each line item includes engineering and overhead cost for the purchase and assembly of equipment.

1.C.2 Process IQOQPQ for any required equipment listed above

Item#
Description
Sub-Total (Range)
4.2 Quality Assurance of Equipment
$123,830- $136,213

Any required special equipment (i.e. not the cleanroom, tables and glues or solvents) must have an IQ OQ PQ qualification conducted.

1.C.3 Process Trials

Item#
Description
Sub-Total (Range)
5 Engineering and Testing of Chemicals
$24,360- $26,796

Chemical testing, in conjunction with equipment, will be necessary to show proof of concept prior to FDA submittal. This item does not include the cost of the chemicals required to facilitate the test. Those costs are broken out as 4.1.9 Startup Product, in the equipment section (1.C.1).

1.C.4 API Validation

Item#
Description
Sub-Total (Range)
6 Active Pharmacological Ingredient Testing
$113,680- $125,048

All APIs are required to be tested and documented prior to FDA submittal.

1.C.5 Stability Testing

Item#
Description
Sub-Total (Range)
8 3 lot shelf life test of API
$66,990- $73,689

The stability testing will verify the stability of the active ingredients in the packaging. 3 tests will be run simultaneously to ensure the validity of the test.

1.C.6 Package Validation

Item#
Description
Sub-Total (Range)
9 Not leaking, sterile, safe
$36,540- $40,194

Once the appropriate sterilization process and barrier are selected you are required to ensure the sterile barrier is integrous.

1.C.7 Date Coda Validation

Item#
Description
Sub-Total (Range)
14 Shelf life test
$16,240- $17,864

Manufacturer can represent a 6 month shelf-life on your labels as allowed by the FDA once device is manufactured. The FDA requires that you conduct a shelf life (aging or date code validation). A shelf life study shall be conducted for all devices. Manufacturer will conduct the test on the selected packaged product in real time and accelerated test methods.

1.D Phase III

Base documentation required for NDA/FDA development and submittal.

1.D.1 NDA Development

Item#
Description
Sub-Total (Range)
12 Engineering and Regulatory
$179,858- $197,844

The NDA Development will consist of the engineering behind taking the drug through the NDA in route to the FDA.

1.D.2 NDA Code Submittal

Item#
Description
Sub-Total (Range)
13 Submittal fees and process
$55,419- $60,961

This cost estimate includes all the fees and provisions necessary for one submittal. These do not include cost of re-submission if it is not approved.