Locum International header

Contact Locum Whats New at Locum IAGIM - The International Association of Generic and Innovative Drug Manufacturers Home Page Download Your Resources Here Online Ordering


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 (mg) USD eFile (Ab)
1 Alendronate Sodium US & EU Tablets 5 - 10 mg
B
1/3 of cost
2 Alendronate Sodium Tablets 40 / 80mg
B
1/3 of cost
3 Aluminium Magnesium Suspension -
A
1/3 of cost
4 Amitriphyline HCl Tablets 10 mg
A
1/3 of cost
5 Azithromycin US & EU Suspension 200 mg
B
1/3 of cost
6 Azithromycin Capsules 250
B
1/3 of cost
7 Azithromycin Tablets 500 & 600
B
1/3 of cost
8 Atenolol + Chlorthalidone (Soon) Tablets 100-50/25
B
1/3 of cost
9 Atenolol US / EU Tablets 50 /100 mg
B
1/3 of cost
10 Amoxicillin Capsules 250 & 500
B
1/3 of cost
10 Ampicillin Na & Sulbactam Na Injection 1g + 0.5g
2g + 1g
B
1/3 of cost
11 Bisoprolol Fumerate / HCTZ=ZIAC Tablets 5, 10, 25 + 6.25 mg
C
1/3 of
full cost
12 Bromhexine Hydrochloride Tablets + Syrup 8mg
B
1/3 of cost
13 Bromocriptine Mesylate Tablets 2.5mg
B
1/3 of cost
14 Bupropion US & EU Tablets 75/100 mg
B
1/3 of cost
15 Buspirone HCl US & EU Tablets 5 mg /10 mg
B
1/3 of cost
16 Carbamazepine = Geigy US & EU Tablets 200mg
B
1/3 of cost
17 Carbamazepine = Geigy ChewTabs ChewTabs 100 mg
C
1/3 of cost
18 Carbamazepine (Extended Release) Geigy TEGRATOL 400 mg XR ER Coated Tab 400 mg
C
1/3 of cost
19 Carbidopa/Levodopa US & EU Tablets 10/100 mg
B
1/3 of cost
20 Carbidopa/Levodopa US & EU Tablets 25/100 mg
B
1/3 of cost
[List 1] [List 2] [List 3] [List 4] [List 5]

NOTE : EULA and IAGIM Rules / Regulations apply to Ready-To-Go CMC Series
Updated annually

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% full content print files

Title 21 Abbreviated e-Files (PDF Format - Low cost electronic preview)
REVIEW
Title 21 abbreviated e-file (pay about a 1/3) of the above price structures is available for developers who would prefer to review the abbreviated commercial formula and summary outline 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.

Review period : 2016/17





HOME


WELCOME | JOURNALS | HANDBOOKS | IAGIM | IAGIM ONLINE | What's NEW | CONTACT | LINKS
BOOKSTORE | DOWNLOAD AREA | ARTICLE of the MONTH
| SPECIAL | FAQ | CONFERENCES
WORLDWIDE SITES | DRUG DEVELOPMENT WORK SHOPS | JOBS | CLIENT PROFILE


CONTACT -|--561 865 6147 -+ (1)-561-376-2224
© 1992-2016/7 Locum International Group. - All Rights Reserved. Web Design by TheSite - A Division of the LIG.