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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 PRODUCTFORMStrength USD eFile (Ab)
99 Silver SulphadiazineCream1%
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.





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