WELCOM TO NITIN LIFESCIENCES

Injectable Formulation

About Lines and Production Capacity

LINE
Ampoules I Ampoules II Ampoules III Ampoules IV FFS (Eye/Ear drop) Vials I Vials II Vials III for Clearwax and Ivocip Dry Injection I

VOLUME
1ml, 2ml, 3ml 2 ml, 5 ml 3 ml 2 ml 5 ml,10ml 30 ml 2 ml 10 ml, up to 50 ml 5ml,10 ml,100 ml

CAPACITY/MONTH
60 Lac per month 50 Lac per month 45 Laces per month 60 Laces per month 20 Laces per month 20 Lac per month 60 Lac per month Actual Capacity 5 Lac per month but Production 1 Lac per month 25 Lac

Up to 3.0gm

Dedicated lines depending on size of vials/Amp.

AMPOULE LINE: Four Ampoule Lines are available at Nitin Lifesciences. Line III is dedicated for 3ml ampoules and IV for 2ml ampoules. The major products manufactured in Ampoule line are Termadol, Doclofenac Sodium, Ranitidine Hydro chloride, Peramacetol etc. VIAL LINE: Three Vial Lines are available at Nitin Lifesciences. Line I is dedicated for 30ml and 50ml , and II lines is used up to 30ml. and Line III is dedicated for Clearwax and Ivocip(Cipla Products) for The major products manufactured in vials lines Gentamycin , Diclofenac Sodium etc. EYE/EAR DROP LINE: One FFS Line are available at Nitin Lifesciences. The Major Product Manufactured in FFS line are Ciprofloxacin, Ofloxacin, Sodium Carboxy Methyl etc. DRY POWDER LINE: There are Single line for dry injection of Cephalosporin as Penem product. The major product are Ceftriaxone sodium, Cefotaxime, Ceftriaxone+Sulbactum, Cefoperazone+Sulbactum, Meropenem,etc. The major client are Ranbaxy , Zydus Cadila ,Torrent,Lupin etc.

Improvements and Implementation at Nitin life

High Beam Torch Implemented at location. Pictorial line clearance check list Implemented. Lux meter for light intensity monitoring implemented. Double Hand Gloves Practices in Sterile Area. UV burning hrs. record implemented. Centralized filter Record implemented. At decartoning stage implemented the Glass Vial handling protocols LOD test started of rubber stoppers for CIPLA Products. Mobile LAF purchased for Filling area. UPS backup provided to all LAF. Rejection analysis started and Log book implemented for every stage(Washing/filling/visual inspection) with type of rejection. 100% Inspection started of Rubber Droppers used in Clearwax pack. Particulate matter testing started at the time of QC analysis of ROPP caps. Clearwax Bulk Analysis started at Location by titration method, now Only finish product sample send to other lab. For Assay Analysis.

YIELD TRENDS
FOR CLEARWAX 10ml
Batch Number ZX2001 ZX2002 ZX2003 MFG. Batch Size in Units 19047 19047 19047 Dispatched qty.+ Samples 17825+64 18150+64 18150+64 Standard Yield Actual Yield In % 93.92 95.63 95.63 Variance % -2.08 -0.37 -0.37

Jan.12 Jan.12 Jan.12

96% 96% 96% 96%

ZX2004
ZX2005 ZX2006 ZX2007

Jan.12
Jan.12 Jan.12 Jan.12

19047
19047 19047 19047

18300+64
18250+64 18300+64 18300+64

96.41
96.15 96.41 96.41

0.41
0.15 0.41 0.41

96%
96% 96% 96%

ZX2008
ZX2011 ZX2012 ZX2013 ZX2014 ZX2015

Jan.12
Feb.12 Feb.12 Feb.12 Feb.12 Mar.12

19047
19047 19047 19047 19047 19047

18200+64
18350+64 17917+60 18300+60 18275+60 18275+60

95.89
96.68 94.38 96.39 96.26 96.26

-0.11
0.68 -7.27 -1.62 0.39 0.26

96%
96% 96% 96% 96%

Cont.
Batch Number ZX2016 ZX2018 ZX2019 ZX2020 ZX2021 ZX2023 ZX2024 ZX2027 MFG. Batch Size in Units 19047 19047 19047 19047 19047 19047 19047 19047 Dispatched qty.+ Samples 18300+60 18300+60 18225+60 18150+60 18300+60 18150+60 18225+60 18200+60 Standard Yield Actual Yield In % 96.39 96.39 96.00 95.61 96.39 95.61 96.00 95.87 Variance % 0.26 0.39 0.00 -0.39 0.39 -0.39 0.00 -0.13

Mar.12 Mar.12 Mar.12 Mar.12 Mar.12 Apr.12 Mar.12 Mar.12

96% 96% 96% 96% 96% 96% 96% 96% 96%

ZX2028
ZX2029

Apr.12
Apr.12

19047
19047

18300+60
18325+60

96.39
96.52

0.39
0.52

96%

For Granicip 3ml

Batch Number ZX2017 ZX2022 ZX2030 MFG. Batch Size in Units 39062 39062 39062 Dispatched Standard Yield qty.+ Samples 30540+504 31760+197 35370+546 92% 92% 92% Actual Yield In % 79.47 81.81 91.95 Variance % -12.53 -10.19 -0.05

Mar.12 Apr.12 Jun.12

For Sulbacip 1 & 2gm

Batch Number

MFG.

Batch Size in Units

Dispatched Standard Yield qty.+ Samples

Actual Yield In %

Variance %

ZX2009 ZX2010 ZX2025 ZX2026

Jan.12 Jan.12 Apr.12 Apr.12

26134 21778 26248 23983

24921+727 20700+729 25200+673 22229+697

96% 96% 96% 96%

98.14 98.40 98.57 95.59

+2.14 +2.40 +2.57 -0.41

Problems faced at Unit

1.
We faced leaching issue after terminal sterilization in Granicip 3ml. Used stopper of GBBRS, Jamnadas. So higher fibers rejection found.

Action Plan:we have taken a trail RFU stopper.

We have done the filling of batch with 2500 RFU Stoppers. Monitoring of % rejection was done during entire filling operation with both Stoppers (RFU & GBBRS) & the average rejection obtained was 2% with RFU Stoppers and 6% with GBBRS(Jamnadas). We did a trail that a tray with all 340 good vials of RFU rubber stoppers (duly marked) was also terminally sterilized along with other trays of Granicip & after terminal sterilization when this tray was again checked for optical rejection then it is observed that 07 vials out of 340 (02.05%) was having rejection of fibres &white particles, and 333 good vials.

Problems faced at Unit

2. Particulate matter observed in ROPP CAPS consignment from Supplier hands. Action Plan:We have started a additional test with QC testing, we have done the particulate matter test.
We have taken a Flask and dipped the 10-20 ROPP caps in purified

water and shacked and after 15 minutes ,we checked the clarity and checked the particulate matter .

Problems faced at Unit

3. Loss observed during storage of Peradicloro benzene & Chlorbutol in store area. Action Plan:Both are volatile materials and meanwhile in previous time change the pack style of container to avoid the maximum loss . Initially material was received in HDPE bags but now its received in fiber drum .

Market & Depo. Complaint

We have no any market and Depot Complaint for any product in Local as well as export .

Deviation & Change Control

No any Deviation & Change control taken in last Six month.

Market Intelligence
One New Product Production started at Nitin life sciences in

Last Month, June 2012 for Abbott .

Product Name API Dosage form Strength :- KenaCort Oral Paste :-Triamcinolone Acetonide :- Suspension :- 40 mg/ml & 10 mg/ml

Nitin Life sciences Started a second New Product ,Sulbacip 1 & 2gm,

API Sulbactum Sodium for CIPLA as LL basis.

And Same Product also started for second Party Eris Lifescineces as

P2P basis

Cont.
Product name :- Marzone SB. 1 gm

Party Name :- Eris Lifescineces Batch size :- 55841 vials MRP :- Rs. 300 vial :- 10ml moulded

Product name :- Marzone SB. 2.0gm

Party Name :- Eris Lifescineces Batch size :- 54144 vials MRP :- Rs. 500 vials :- 20 ml moulded

Thanks