TITLE 21
READY-TO-GO CMC SERIES
GENERIC DRUG DEVELOPMENT CMC KNOW-HOW LIST
Contents of a Ready-To-Go Dossier
RTG | DRUG PRODUCT | FORM | Strength | USD | Sterling |
80 | Naproxen Sodium US/EU |
DR
Tablets
|
220 mg |
C
|
C
|
81 | Naproxen Sodium US/EU |
DR
Tablets
|
275 / 550mg |
C
|
C
|
82 | Norfloxacin USP |
Tablets
|
400 mg |
B
|
B
|
83 | Ofloxacin (= TARAVID) US/EU |
Tablets
|
100/200/400 mg |
C
|
C
|
84 | Oxolamine |
Syrup
|
10 mg/mL |
B
|
B
|
86 | Paclitaxel Conc. for Injection (vials) |
6mg/mL
|
30+100mg |
F
|
F
|
86 | Paracetamol - Alcohol Free + sugar free / + dye-free |
Clear Syrup
Clear Liquid A non-suspension preparation |
80/120/125 mg Strawberry Flavour |
B
|
B
|
86 | Paracetamol - Alcohol Free + sugar free / + dye-free |
Clear Syrup
Clear Liquid A non-suspension preparation |
80/120/125 mg Fruit Flavour |
B
|
B
|
87 | Paracetamol Chewable Fruit Flavors |
ChewTabs
|
160 mg |
B
|
B
|
88 | Pentoxifylline( = Hoechst 400 XL) |
ER
Tablets
|
400 mg |
C
|
C
|
89 | Penfluridol |
Capsules
|
10 mg |
B
|
B
|
90 | Potassium Chloride 600+1200 mg |
SR
Tablets
|
10+20 mEq |
D
|
D
|
91 | Piroxicam US/EU |
Capsules
|
20 mg |
A
|
A
|
92 | Quinidine Bisulphate Tetrahydrate |
Tablets
|
250 mg |
A
|
A
|
93 | Ranitidine HCl |
Tablets
|
150/300 mg |
B
|
B
|
94 | Simvastatin US/EU |
Tablets
|
5 / 10mg |
B
|
B
|
95 | Simvastatin US/EU |
Tablets
|
20 / 40 / 80mg |
C
|
C
|
96 | Scopolamine Butylbromide |
Tablets
|
10 mg |
A
|
A
|
97 | Selegiline US/EU |
Tablets
|
5 /10 mg |
A
|
A
|
98 | Sotalol ( = Betapace™/ Berlex) |
Tablets
US/EU |
80/120/160 240 mg |
C
|
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 $ | ||
A - $2999 - $3499 USD | B - USD $2999 - $3999 | C - USD $3999 - $4999 |
D - USD $4500 - $4999 | E - USD $5000 - $6999 | SP - USD $7000 - $7990 |
DOWNLOAD The Ready-To-Go List - (PDF Format) |
IAGIM's Ready-To-Go CMC Drug Development Know-How Series may be downloaded
as a current reference source. ![]() |
CONTACT :| USA +1 561
865 6147
-| info @ Locum
co.il