2. INTRODUCTION:
Sharon commissioned Oral Solid Dosage Formulation Plant at Dehradun in 2007.
Focused on providing world class Contract Manufacturing Services, this facility
is d i
i designed as per guidelines of USFDA, TGA ( A t li ) , EDQM, ANVISA
d id li f USFDA Australia EDQM
(BRAZIL).
Capable of carrying out development & manufacturing of non sterile, non-beta
lactum, non-cephalosporin tablets and capsules. Proposed dosage forms are
Sachet Filling and Dry Syrups.
Annual capacity of over 4500 million units of tablets and Capsules.

3. CERTIFIED BY..
Other Approvals:
pp :
- National Drug Authority, Uganda
- Pharmacy & Poison Board, Kenya
- Ministry of Healthcare & Nutrition, Sri Lanka
- Ministry of Health – Vietnam
- Ministry of Public Health and Population – Republic of Yemen
- Ministry of health and sanitation, Ivory Coast

4. Two development sites at Mumbai & Dehradun.
Focused on development of Oral solid dosage; Tablet & Capsules.
p g p
Besides the immediate release products, specialization in development of Modified Release & Bi-
layered products.
In- house analytical laboratory to support in Method Development, Validation & Stability Analysis.
Tie-ups with External Labs for performing of Clinical studies as and when required.

5. PLANT CAPACITY ANALYSIS
GRANULATION WG1 WG2 WG3 DG1 WG4 WG4
250 KG 120 KG 60 KG 350 KG 500 KG* 500 KG *
COMPRESSION/ CMP-1 CMP-2 CMP-3 CF-1 CMP-4 CMP-5 CMP-6
CAPSULE 45 STN 65 STN 27 STN LEGACY 45 STN* 65 STN 8* 45 STN*
FILLING
Tab 680 Tab 200 Tab 200 Caps Tab 680 Tab 200 Tab 680
REF PRODUCT mg mg mg Pellets 280 mg mg mg
SHIFT OUTPUT 0.972
0 972 1.872
1 872 7.776
7 776 0.80
0 80 0.972
0 972 1.872
1 872 0.972
0 972
(IN MILLION)
DAILY OUTPUT 2.916 5.616 2.3328 2.40 2.916 5.616 2.916
(IN MILLION)
PP-7 Strip PP-8 Strip PP-9 Bulk
PACKAGING PP-1 PP-2 PP-3 PP-4 PP-5 PP-6
Packing Packing Packing
LINE BQS EL - 3020 EL 2500 EL 2500 BQS* BQS*
Tab 680 Tab 200 Tab 200 Caps
p Tab 680 Tab 200
REF PRODUCT mg mg mg Pellets 280 mg mg
SHIFT OUTPUT
(IN MILLION)
( ) 1.5 1.5 0.8 0.8 1.5 1.5
DAILY OUTPUT
(IN MILLION) 4.5 4.5 2.4 2.4 4.5 4.5

6. TOTAL
BOTTLE NECK STAGE PACKAGING PACKAGING PACKAGING PACKAGING PACKAGING PACKAGING BEFORE TOTAL AFTER
LINE LINE LINE LINE LINE* LINE* EXPANSION EXPANSION
MILLION MILLION
DAILY OUTPUT (IN
MILLION) 4.5 4.5 2.4 2.4 4.5 4.5 13.8 22.8
DAILY DELIVERABLE
CAPACITY 3.15 3.15 1.68 1.68 3.15 3.15 9.66 15.96
ANNUAL
742.5 742.5 396 396 742.5 742.5 2898 4788
DELIVERABLE
CAPACITY MILLION
NOTES :
3 shifts working
Products used as reference are only i di i to give id of tablet size /Bli
P d d f l indicative i idea f bl i /Blister size.
i
Machines Lines proposed in expansion area marked with '*'
Expansion area building is already constructed. Expansion is expected to complete by June 2012.
A Pelletisation line with Two 600 Liters Glatt fluidized bed processors is also being considered to be commissioned.
Granulation capacities are not a constrain hence productivity is not indicated. Only line capacity us mentioned. WG -
indicates line with high shear mixer and fluid bed dryer and DG indicates dry granulation.
EQUIPMENTS NOT CONSIDERED IN CAPACITY CALCULATION
Additional to above equipments/lines 3 coating machines are available : one 24"/30" interchangeable, one 60“ and 2
66” are proposed i expansion.
d in i
Bulk packaging line which is capable of 120 bottles with a count of 100 tablets.
Two 10 track strip packaging machines.

7. WET
GRANULATION
LOT SIZE
WG3- 30 KGS
WG2-
WG2 100 KGS
WG1- 250 KGS
WG 4 & 5 - 500 KGS * 2
BLENDING
LOT SIZE
DG1- 350 OR 750 LITRE
WG2- 750 OR 1250 LITRE
DG2- 5000 LITRE

8. TABLET
COMPRESSION
27 STATION DOUBLE ROTARY – 1 NOS
45 STATION DOUBLE ROTARY – 3 NOS
65 STATION DOUBLE ROTARY – 2 NOS
The compression machines have auto weight check, individual weight variation, hardness, thickness,
online metal detection & de-dusting units, SCADA acquisition on PC & PLC.
All compression lines are capable of compressing Bi-layered tablets
Provision for online tablet inspection

9. LEGEND 2500: CAPSULE FILLING MACHINE
SEVERAL FILLING COMBINATIONS:
Pellets + Powder
Pellets + Micro Tablets
Powder + Micro Tablets
Capsule in Capsule

10. COATING
26 32
26” / 32” DUAL- PAN AUTOCOATER
60” AUTOCOATER - 1 NO
66” AUTOCOATER - 2 NOS

11. PACKAGING LINE - 1
1. BULK PACKING LINE
Completely integrated hi-speed bottle filling line with maximum
capacity of 120 bottles/min for bottle sizes of 15 to 150 ml .
The LINE COMPRISES OF :
 Automatic Un-scrambler  Automatic Check Weigher
 Ionized Air Jet Washing  Automatic cotton filling
 Desiccant Insertion  Cap Sealing
C S li
 Silica Gel Canister Inserter  Induction Sealing Machine
 Electronic Counting & Filling  Automatic Sticker labeling

12. PACKAGING LINES
 PACKAGING LINES – 2 , 3, 4
Three PAM’s BQS Model Capable of 450 BLISTERS/MIN on
PVC - ALU and 280 BLISTERS/MIN on ALU – ALU
 PACKAGING LINE - 5
ELMACH’s EPI 3020 BLITZ Model Capable of
upto 600 BLISTERS/MIN on PVC - ALU.
This Machine is also capable of handling
p g
ALU - ALU blisters
 PACKAGING LINE – 6 & 7
Two ELMACH’s EPI 2500 for handling
g
PVC - ALU has a rated output of
250 BLISTERS/MIN
 PACKAGING LINE – 8 & 9
Two Strip packaging machines with
capable of packaging approx 1 million
tablets a shift.
bl hif

13. PACKAGING LINES FEATURES
 Lines are equipped with camera detection system for missing
and broken tablets, print registration facility.
 All packaging lines are suitably linked to fully automated /
semi automated cartoning
cartoning.
 All lines have check weighers.
 Carton sealing and shrink wrap facility are also available
available.
 Facility of barcode printing on shippers available.

14. SECONDARY PACKAGING
PRIVATE LABELLING:
BRANDED PRODUCTS BULK PACKING:

15. » Chillers with over 700 Tonnes of Refrigeration Capacity
» B ild U Z
Build-Up Zones t classified areas are provided with all Corridors at P iti pressure
to l ifi d id d ith ll C id t Positive
compared to the Core Rooms.
» Over 50 AHU’s suitable for 50-55% Rh & in certain areas 40-45% Rh. Portable
dehumidifiers il bl for further d i in Rh.
d h idifi available f f h reduction i Rh
» Ventilation and Exhaust Units in all technical area
» Air Quality in the Service floor is also under control
of Ventilation units.
» Building Management system to monitor
the facility and control all HVAC units
units.
» All Core areas – Class 100,000
» Micro lab – Class 10,000 & Class 1000

16. WATER SYSTEM
 2000 liters per hour Purified Water Generation System
System.
 Uses Reverse Osmosis & E D I systems.
 3000 liters Storage Capacity
g p y
 Closed Loop Distribution Loop
 Weekly Heat Sanitization programme.
 In-house daily monitoring of water quality.

17.  Over 300 sq mtrs of quality control labs.
In-house provision for all pharmacopeia tests.
Contracts with External Labs for specialized
tests such as NMR, FTIR, MS etc
 In house provision for conducting
Stability Studies
In house fully equipped Micro Bio Lab
 Over 6 HPLC systems with
y
Auto-samplers

18. » C bl of h dli DEVELOPMENT & MANUFACTURING P j
Capable f handling Projects.
» For Strategic Partners ; In-house API Production at our GMP Facilities is available
to improve sustainability.
» Hi h l l of A
High level f Automation & Ad
i Adequate Q li checks
Quality h k
» Well Staffed Production, Engineering & Quality Teams headed by Qualified
Personnel with Experience in Regulated Markets.
» E t
External C
l Consultants engaged t give T i i
lt t d to i Training and
d
Guidance on GMP.
» ‘Commitments’ with regards to Quality and Delivery.
» In-house Regulatory Affairs Team to support in
Dossier Compilation & Compliance.