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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.