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TITLE 19 - HANDBOOK SERIES TITLE 21 - CMC Ready-To-Go Series


TITLE 21
READY-TO-GO CMC SERIES

GENERIC DRUG DEVELOPMENT CMC KNOWHOW

Contents of a Ready-To-Go Dossier

RTG DRUG PRODUCT FORM Strength USD eFile (Ab)
80 Naproxen Sodium   US/EU
DR Tablets
220 mg
C
1/3 of C
81 Naproxen Sodium   US/EU
DR Tablets
275 / 550mg
C
1/3 of C
82 Norfloxacin USP
Tablets
400 mg
B
1/3 of B
83 Ofloxacin (= TARAVID) US/EU
Tablets
100/200/400 mg
C
1/3 of C
84 Oxolamine
Syrup
10 mg/mL
B
1/3 of B
86 Paclitaxel Conc. for Injection (vials)
6mg/mL
30+100mg
F
1/3 of F
86 Paracetamol - Alcohol Free + sugar free / + dye-free
Clear Syrup
Clear Liquid
A non-suspension preparation
80/120/125 mg
Strawberry Flavour
B
1/3 of B
  Paracetamol - Alcohol Free + sugar free / + dye-free
Clear Syrup
Clear Liquid
A non-suspension preparation
80/120/125 mg Fruit Flavour
B
1/3 of B
87 Paracetamol Chewable Fruit Flavors
ChewTabs
160 mg
B
1/3 of B
88 Pentoxifylline( = Hoechst 400 XL)
ER Tablets
400 mg
C
1/3 of C
89 Penfluridol
Capsules
10 mg
B
1/3 of B
90 Potassium Chloride 600+1200 mg
SR Tablets
10+20 mEq
D
1/3 of D
91 Piroxicam US/EU
Capsules
20 mg
A
1/3 of A
92 Quinidine Bisulphate Tetrahydrate
Tablets
250 mg
A
1/3 of A
93 Ranitidine HCl
Tablets
150/300 mg
B
1/3 of B
94 Simvastatin US/EU
Tablets
5 / 10mg
B
1/3 of B
95 Simvastatin US/EU
Tablets
20 / 40 / 80mg
C
1/3 of C
96 Scopolamine Butylbromide
Tablets
10 mg
A
1/3 of A
97 Selegiline US/EU
Tablets
5 /10 mg
A
1/3 of A
98 Sotalol ( = Betapace™/ Berlex)
Tablets
US/EU
80/120/160 240 mg
C
1/3 of C
[List 1] [List 2] [List 3] [List 4] [List 5]
NOTE : EULA and IAGIM Rules / Regulations apply to Ready-To-Go CMC Series

Title 21 Ready-To-Go Price Range - US Dollars $ value (Extended Benefit Plans)
A - $2999 - $3499 USD B - USD $2999 - $3999 C - USD $3999 - $4999
D - USD $4500 - $4999 E - USD $5000 - $6999 F - USD $7000 - $7990
Abbreviated Title 21 e-files reduce file cost by 66% of full content print files


Title 21 Abbreviated e-Files (PDF Format - Low cost electronic preview)
PREVIEW
Title 21 abbreviated e-file (pay about a 1/3 to a full 1/4) of the above price structures are available for developers who would prefer to review the formula and process before purchasing the complete full length print volume. The print cost then reduced by the abbreviated efile amount paid.

SINGLE DOSE & MULTIDOSE DOSE COSTING
* Single dose (lowest $ amount) and multidose (highest $ amount) For IAGIM extended benefit plans, the exact amounts are calculated per item and costs increase proportionally as the number of strengths increase. (CMC files are presented per product containing all the unit strengths and not per strength or part thereof)

IAGIM's Ready-To-Go CMC Drug Development Know-How Series may be downloaded as a current reference source.




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