R&D budget for product DMF submissio

Project Title Meropenem

Synthesis
RM for R&D 20
Charcterization 5
Elemental analysis 5
Nitrosamine impurity 10
Reference stanadard/Working stanadard 10
Unknown Impurity Idetification (Mass, LCMS) 2
Method Development 10
Impurity purchase 10
Biological product analysis (Plasma/ Human thrombin, 0
Antitrombin/Chromogenic substrate,USP standard for
potency analysis)

Analytical
Reagent 2
column 3
solvents (HPLC grade) 2
Total (Lakhs) 79

Note: 1. During submission review if any query comes and additional lab work / Outside testing is required then t
Note:2. If available purchased raw materials supplier is not able/not ready to give support for DMF supporting do
Erta and Piperacillin case).
Piperacillin acid red coloured budgeted value can be deleted as Piperacillin validation planned in next month. He
Meropenem RM 20 Lakhs if current supplier is able to give DMF document support then this amount is not requir
 R&D budget for product DMF submission (Budget in Lakhs)
Imipenem+Cilastatin Blend Ertapenem Sodium Piperacillin Tazobactam Heparin

20 0 1 5 10
10 7 5 5 5
10 0 5 5 5
20 0 10 10 10
10 0 10 10 10
5 0 2 2 0
20 0 10 10 0
20 0 10 10 0
0 0 0 0 10

4 0 2 2 2
6 0 3 3 3
4 0 2 2 2
129 7 60 64 57

onal lab work / Outside testing is required then this projected budget value may increased.
/not ready to give support for DMF supporting documentation work then again approved vendor RM sourcing will increase budget valu

Piperacillin validation planned in next month. Hence all study will performed for plant validation batches directly in QC budget.
document support then this amount is not requird.
 Enoxaparin Total (in Lakhs)

12 68
5 42
5 35
10 70
10 60
0 11
0 50
0 50
10 20

2 14
3 21
2 14
59 455

M sourcing will increase budget value (Like

atches directly in QC budget.