WELCOM TO NITIN LIFESCIENCES

Injectable Formulation

About Lines and Production Capacity

LINE VOLUME CAPACITY/MONTH

Ampoules I 1ml, 2ml, 3ml 60 Lac per month

Ampoules II 2 ml, 5 ml 50 Lac per month

Ampoules III 3 ml 45 Laces per month

Ampoules IV 2 ml 60 Laces per month

FFS (Eye/Ear drop) 5 ml,10ml 20 Laces per month

Vials I 30 ml 20 Lac per month

Vials II 2 ml 10 ml, up to 50 ml

60 Lac per month

Vials IIIfor Clearwax and Ivocip

5ml,10 ml,100 ml Actual Capacity 5 Lac per month but

Production 1 Lac per monthDry Injection I Up to 3.0gm 25 Lac

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 TRENDSFOR CLEARWAX 10ml

Batch Number

MFG. Batch Size in Units

Dispatched qty.+ Samples

Standard Yield

Actual Yield In %

Variance %

ZX2001 Jan.12 19047 17825+64 96% 93.92 -2.08ZX2002 Jan.12 19047 18150+64 96% 95.63 -0.37ZX2003 Jan.12 19047 18150+64 96% 95.63 -0.37ZX2004 Jan.12 19047 18300+64 96% 96.41 0.41ZX2005 Jan.12 19047 18250+64 96% 96.15 0.15ZX2006 Jan.12 19047 18300+64 96% 96.41 0.41ZX2007 Jan.12 19047 18300+64 96% 96.41 0.41ZX2008 Jan.12 19047 18200+64 96% 95.89 -0.11ZX2011 Feb.12 19047 18350+64 96% 96.68 0.68ZX2012 Feb.12 19047 17917+60 96% 94.38 -7.27ZX2013 Feb.12 19047 18300+60 96% 96.39 -1.62ZX2014 Feb.12 19047 18275+60 96% 96.26 0.39ZX2015 Mar.12 19047 18275+60 96% 96.26 0.26

Cont.

Batch Number

MFG. Batch Size in Units

Dispatched qty.+ Samples

Standard Yield

Actual Yield In %

Variance%

ZX2016 Mar.12 19047 18300+60 96% 96.39 0.26ZX2018 Mar.12 19047 18300+60 96% 96.39 0.39ZX2019 Mar.12 19047 18225+60 96% 96.00 0.00ZX2020 Mar.12 19047 18150+60 96% 95.61 -0.39ZX2021 Mar.12 19047 18300+60 96% 96.39 0.39ZX2023 Apr.12 19047 18150+60 96% 95.61 -0.39ZX2024 Mar.12 19047 18225+60 96% 96.00 0.00ZX2027 Mar.12 19047 18200+60 96% 95.87 -0.13ZX2028 Apr.12 19047 18300+60 96% 96.39 0.39ZX2029 Apr.12 19047 18325+60 96% 96.52 0.52

For Granicip 3ml

Batch Number

MFG. Batch Size in Units

Dispatched qty.+ Samples

Standard Yield

Actual Yield In %

Variance %

ZX2017 Mar.12 39062 30540+504 92% 79.47 -12.53ZX2022 Apr.12 39062 31760+197 92% 81.81 -10.19ZX2030 Jun.12 39062 35370+546 92% 91.95 -0.05

For Sulbacip 1 & 2gm

Batch Number

MFG. Batch Size in Units

Dispatched qty.+ Samples

Standard Yield

Actual Yield In %

Variance %

ZX2009 Jan.12 26134 24921+727 96% 98.14 +2.14

ZX2010 Jan.12 21778 20700+729 96% 98.40 +2.40

ZX2025 Apr.12 26248 25200+673 96% 98.57 +2.57

ZX2026 Apr.12 23983 22229+697 96% 95.59 -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:- KenaCort Oral Paste

API :-Triamcinolone Acetonide

Dosage form :- Suspension

Strength :- 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