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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)
99	Silver Sulphadiazine	Cream	1%	A	1/3 of A
100	Tamoxifen EU Aqueous Coated	Tablets	10 / 20 mg	B	1/3 of B
101	Tamoxifen EU Aqueous Coated	Tamoxifen EU	30 / 40mg	C	1/3 of C
102	Tamoxifen US Aqueous Coated	Tablets	10/20/40mg	B	1/3 of B
103	Tamoxifen US Non Coated	Tablets	10/20/40mg	B	1/3 of B
104	Terbutaline Sulfate	Syrup	0.3 mg/mL	B	1/3 of B
105	Terazosin US/EU	Tablets	1mg / 2mg	B	1/3 of B
106	Terfenazine US/EU	Tablets	60 mg	B	1/3 of B
107	Tetrahydrozoline HCl USP	Eye Drops	2,5mg/5mL	B	1/3 of B
108	Ticlopidine US/EU	Tablets	250 mg	B	1/3 of B
109	Timolol maleate Drops USP	Eye Drops	0.25 / 0.5%	C	1/3 of C
110	Tolmetin Sod. US/EU	Capsules	400 mg	B	1/3 of B
111	Tolmetin Sod. US/EU	Tablets	600 mg	B	1/3 of B
112	Trazodone US/EU	Tablets	50/100 mg	C	1/3 of C
113	Trazodone US/EU	Tablets	150 mg	C	1/3 of C
114	Tretinoin	Cream USP	0.025% 0.05%	C	1/3 of C
115	Sulfamethoxazole Trimethoprim	Tablets USP	80/400mg	B	1/3 of B
116	Sulfamethoxazole Trimethoprim DS	Tablets USP	160/800mg	C	1/3 of C
117	Sulfamethoxazole Trimethoprim	Suspension	80/400mg	B	1/3 of B
118	Sodium Valproate	Syrup	4 / 8 /mg	B	1/3 of B
119	Verapamil Hydrochloride	Tablets	40/80/120mg	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	SP - 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) of the above price structures are available for developers who would prefer to review the outline summary commercial formula and outline abbreviated process before purchasing the complete 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.