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Budget US+ Query

This document appears to be a budget breakdown for fiscal year 2021 projects between the US and EU. It includes line items for API procurement, development excipients and materials, scale-up excipients and materials, packaging materials, and exhibit batches. The total amounts are not included, as the document contains many line items without quantities or amounts specified. It covers projects such as various dosage forms of drugs like vancomycin, dofetilide, metformin, and others.

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syedburhanuddinmoin
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© © All Rights Reserved
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
39 views

Budget US+ Query

This document appears to be a budget breakdown for fiscal year 2021 projects between the US and EU. It includes line items for API procurement, development excipients and materials, scale-up excipients and materials, packaging materials, and exhibit batches. The total amounts are not included, as the document contains many line items without quantities or amounts specified. It covers projects such as various dosage forms of drugs like vancomycin, dofetilide, metformin, and others.

Uploaded by

syedburhanuddinmoin
Copyright
© © All Rights Reserved
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
You are on page 1/ 6

Budget FY 21 : US EU QR FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21

Exhibit Batches

Tools for Excipient and Packaging Materials for


API for Development API for Scale-up Excipient & Packaging Material for Development + Scale-up API for Exhibit Batch
Development Exhibit Batches

Packaging Packaging Packaging


Excipient for Excipient for Material for Device Material for Excipients for Material for
No. Project Rate / KG Quantity Amount API Qty Amount Development Scale-up Development Devlopment Scale-up Amount API Qty Amount EB EB
US Grid Original ANDAs

Vancomycin Injection 500mg, 1g, 5g & (750 0.79 - - - - - - - - - - - - - -


1 mg &10 g)
2 Dofetilide Capsules 164.16 - - - - - - - - - - -
3 Metformin ER Tabs - - - - - - - - - - - - -
4 Glycopyrrolate Injection 26.55 - - - - - - - - - - - -
5 Vigabatrin POS 1.06 - - - - - - - - - - - - -
6 Isoproterenol Hydrochloride Injection - - - - - - - - - - - - - -
7 Enoxaparin Injection (MDV and PFS) - - - - - - - - - - - - - -
Mesalamine DR Tablets 800 mg (Asachol)
8
Mesalamine ER Capsules (Pentasa®), 250
9 mg, 500 mg
10 Project Liliac
11 Epinephrine Injection
Lacosamide Oral Solution
Brimonidine Tartrate Ophthal sol.
Norepinephrine Bitartrate Injection
Ephedrine Sulfate IV Injection
Mirabegron ER Tablet
Gabapentin Tablet
Rivaroxaban Tablet
Famotidine + Ibuprofen Oral Tablet

Total (US) - - - - - - - - - - -
US Query Response
1 Latanoprost Ophthalmic Solution, 0.01% 1,740.00 - - - - - - - - - - - - -
Acetaminophen Injection, 1000 mg/ 100 mL (10
2 mg/mL) 0.03 - - - - - - - - - - - - - -
Regadenoson Injection, 0.4 mg/5 mL (0.08
3 mg/mL) - - - - - - - - - - - - - - -
Clindamycin Palmitate HCl for Oral Solution
4 USP, 75 mg/5 mL - - - - - - - - - - - - - - -
Carbamazepine ER Tablet, 100 mg, 200 mg and
5 400 mg - - - - - - -

Page 1 of 6
Budget FY 21 : US EU QR FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21
Exhibit Batches

Tools for Excipient and Packaging Materials for


API for Development API for Scale-up Excipient & Packaging Material for Development + Scale-up API for Exhibit Batch
Development Exhibit Batches

Packaging Packaging Packaging


Excipient for Excipient for Material for Device Material for Excipients for Material for
No. Project Rate / KG Quantity Amount API Qty Amount Development Scale-up Development Devlopment Scale-up Amount API Qty Amount EB EB
Ropivacaine Hydrochloride Injection USP, 2, 5
6 and 10 mg/mL - - - - - - - - - - - - - - -
7 Paliperidone ER Tablet 3.38 - - - - - - - - - - - - - -

Total ( US Query Response) - - - - - - - - - - -


Total ( US ANDA & Query Response) - - - - - - - - - - - - - -
UK Projects

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Budget FY 21 : US EU QR oFY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21
t
r
Exhibit Batches
B
D Innovator Samples for Development / Pilot / Pivotal / Non RLD / Diluent Analysis Charges
Excipient and Packaging Materials
a for Tools & Change Parts for
e
Exhibit Batchest Exhibit Batches
v
c
e
h
l
e
o
s
p
m
e Devices for Amount for Amount of RLD Qty for RLD Qty for RLD Qty for Non RLD / Filter Consultancy Total Cost of Analytical
No. Project n EB Tools Change Parts Rate Dev. Amount Pilot BE Amount Pivotal BE Amount Diluent Qty Amount Validation Charges FRD cost for TT
t
US Grid Original ANDAs

Vancomycin Injection 500mg, 1g, 5g & (750### - - - 0.41 - - - - - - - - - - - -


1 mg &10 g)
2 Dofetilide Capsules ### - - - 0.02 - - - - - - -
3 Metformin ER Tabs ### - - - - - - - - - - - - - -
4 Glycopyrrolate Injection ### - - - - - - - - - - - - -
5 Vigabatrin POS ### - - - 5.00 - - - - - - - - -
6 Isoproterenol Hydrochloride Injection ### - - - 1.77 - - - - - - - - - - - -
7 Enoxaparin Injection (MDV and PFS) ### - 4.00 - 0.06 - - - - - - - - - - -
Mesalamine DR Tablets 800 mg (Asachol)
8
Mesalamine ER Capsules (Pentasa®), 250
9 mg, 500 mg
10 Project Liliac
11 Epinephrine Injection
Lacosamide Oral Solution
Brimonidine Tartrate Ophthal sol.
Norepinephrine Bitartrate Injection
Ephedrine Sulfate IV Injection
Mirabegron ER Tablet
Gabapentin Tablet
Rivaroxaban Tablet
Famotidine + Ibuprofen Oral Tablet

Total (US) ### - 4.00 - - - - - - - - -


US Query Response
1 Latanoprost Ophthalmic Solution, 0.01% ### - - - - - - - - - - - - - - -
Acetaminophen Injection, 1000 mg/ 100 mL (10
2 mg/mL) ### - - - 0.82 - - - - - - - - - - - -
Regadenoson Injection, 0.4 mg/5 mL (0.08
3 mg/mL) ### - - - 0.27 - - - - - - - - - - -
Clindamycin Palmitate HCl for Oral Solution
4 USP, 75 mg/5 mL ### - - - - - - - - - - - - - - -
Carbamazepine ER Tablet, 100 mg, 200 mg and
5 400 mg ### - - - - - - - - - - - - - -

Page 3 of 6
E
A
x
P
h
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b
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i
Budget FY 21 : US EU QR oFY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21
t
r
Exhibit Batches
B
D Innovator Samples for Development / Pilot / Pivotal / Non RLD / Diluent Analysis Charges
Excipient and Packaging Materials
a for Tools & Change Parts for
e
Exhibit Batchest Exhibit Batches
v
c
e
h
l
e
o
s
p
m
e Devices for Amount for Amount of RLD Qty for RLD Qty for RLD Qty for Non RLD / Filter Consultancy Total Cost of Analytical
No. Project n EB Tools Change Parts Rate Dev. Amount Pilot BE Amount Pivotal BE Amount Diluent Qty Amount Validation Charges FRD cost for TT
t
Ropivacaine Hydrochloride Injection USP, 2, 5
6 and 10 mg/mL ### - - - - - - - - - - - - - -
7 Paliperidone ER Tablet ### - 4.50 - 0.04 - - - - - - - - - -

Total ( US Query Response) ### - 4.50 - 1.12 - - - - - - - - - - -


Total ( US ANDA & Query Response)### - 8.50 - - - - - - - - - - -
UK Projects

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Budget FY 21 : US EU QR oFY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21
t
r
B
D
Analysis Charges Bio Study Cost Outsourced Project Cost
a
e
t
v
c
e
h
l Outsourced Outsourced
e
o Outsourced Project Cost Project Cost
s
p Outsourced Project Cost (DEV (DEV
m Analytical Analytical (DEV INSIDE OUTSIDE OUTSIDE
e Cost Cost ( All Pilot BE Pilot BE (Bio Pivotal Pre Litigation MFG MFG MFG
No. Project n (E& L) Projects) Clinical Analytical) Clinical Pivotal BE Filing Cost IP Cost Cost Litigation OUTSIDE) INSIDE ) OUTSIDE Total Cost FY 20
t
US Grid Original ANDAs

Vancomycin Injection 500mg, 1g, 5g & (750### - - - - - - - - - - - - 0.00


1 mg &10 g)
2 Dofetilide Capsules ### - - - - - - - - - - - - 0.00
3 Metformin ER Tabs ### - - - - - - - - - 0.00
4 Glycopyrrolate Injection ### - - - - - - - - - - 0.00
5 Vigabatrin POS ### - - - - - - - - - - 0.00
6 Isoproterenol Hydrochloride Injection ### - - - - - - - - - - - - 0.00
7 Enoxaparin Injection (MDV and PFS) ### - - - - - - - - - - - - 0.00
Mesalamine DR Tablets 800 mg (Asachol)
8
Mesalamine ER Capsules (Pentasa®), 250
9 mg, 500 mg
10 Project Liliac
11 Epinephrine Injection
Lacosamide Oral Solution
Brimonidine Tartrate Ophthal sol.
Norepinephrine Bitartrate Injection
Ephedrine Sulfate IV Injection
Mirabegron ER Tablet
Gabapentin Tablet
Rivaroxaban Tablet
Famotidine + Ibuprofen Oral Tablet

Total (US) ### - - - - - - - - - - - - - -


US Query Response
1 Latanoprost Ophthalmic Solution, 0.01% ### - - - - - - - - - - - - - 0.00
Acetaminophen Injection, 1000 mg/ 100 mL (10
2 mg/mL) ### - - - - - - - - - - - - - 0.00
Regadenoson Injection, 0.4 mg/5 mL (0.08
3 mg/mL) ### - - - - - - - - - - - - 0.00
Clindamycin Palmitate HCl for Oral Solution
4 USP, 75 mg/5 mL ### - - - - - - - - - - - - - 0.00
Carbamazepine ER Tablet, 100 mg, 200 mg and
5 400 mg ### - - - - - - - - - - - - - 0.00

Page 5 of 6
E
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Budget FY 21 : US EU QR oFY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21 FY 21
t
r
B
D
Analysis Charges Bio Study Cost Outsourced Project Cost
a
e
t
v
c
e
h
l Outsourced Outsourced
e
o Outsourced Project Cost Project Cost
s
p Outsourced Project Cost (DEV (DEV
m Analytical Analytical (DEV INSIDE OUTSIDE OUTSIDE
e Cost Cost ( All Pilot BE Pilot BE (Bio Pivotal Pre Litigation MFG MFG MFG
No. Project n (E& L) Projects) Clinical Analytical) Clinical Pivotal BE Filing Cost IP Cost Cost Litigation OUTSIDE) INSIDE ) OUTSIDE Total Cost FY 20
t
Ropivacaine Hydrochloride Injection USP, 2, 5
6 and 10 mg/mL ### - - - - - - - 0.00
7 Paliperidone ER Tablet ### - - - - - - - 0.00

Total ( US Query Response) ### - - - - - - - - - - - - - -


Total ( US ANDA & Query Response)### - - - - - - - - - - - - - -
UK Projects

Page 6 of 6

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