Business Division: Finished Dosage

INTRODUCTION:

Sharon commissioned Oral Solid Dosage Formulation Plant at Dehradun in 2007.

Focused on providing world class Contract Manufacturing Services, this facility i d i d id li f USFDA TGA ( A t li ) EDQM ANVISA is designed as per guidelines of USFDA, TGA ( Australia ) , EDQM, ANVISA (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.

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

Two development sites at Mumbai & Dehradun.Two development sites at Mumbai & Dehradun.

Focused on development of Oral solid dosage; Tablet & Capsules.Focused on development of Oral solid dosage; Tablet & Capsules.p g pp g p

Besides the immediate release products, specialization in development of Modified Release & Bi-layered products. 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. 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. Tie-ups with External Labs for performing of Clinical studies as and when required.

GRANULATION WG1 WG2 WG3 DG1 WG4 WG4

PLANT CAPACITY ANALYSIS

250 KG 120 KG 60 KG 350 KG 500 KG* 500 KG *

COMPRESSION/CAPSULE FILLING

CMP-145 STN

CMP-265 STN

CMP-327 STN

CF-1LEGACY

CMP-445 STN*

CMP-565 STN 8*

CMP-645 STN*

FILLING

REF PRODUCTTab 680

mgTab 200

mgTab 200

mgCaps

Pellets 280Tab 680

mgTab 200

mgTab 680

mg

SHIFT OUTPUT 0 972 1 872 7 776 0 80 0 972 1 872 0 972SHIFT OUTPUT(IN MILLION)

0.972 1.872 7.776 0.80 0.972 1.872 0.972

DAILY OUTPUT (IN MILLION)

2.916 5.616 2.3328 2.40 2.916 5.616 2.916

PACKAGING LINE

PP-1BQS

PP-2EL - 3020

PP-3EL 2500

PP-4EL 2500

PP-5 BQS*

PP-6BQS*

PP-7 Strip Packing

PP-8 Strip Packing

PP-9 Bulk Packing

Tab 680 Tab 200 Tab 200 Caps Tab 680 Tab 200 REF PRODUCT

Tab 680 mg

ab 200 mg

ab 200 mg

pPellets 280

Tab 680 mg

ab 200 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

BOTTLE NECK STAGE PACKAGING LINE

PACKAGING LINE

PACKAGING LINE

PACKAGING LINE

PACKAGING LINE*

PACKAGING LINE*

TOTAL BEFORE

EXPANSION TOTAL AFTER EXPANSION LINE LINE LINE LINE LINE* LINE* EXPANSION

MILLIONEXPANSION

MILLION

DAILY OUTPUT (IN MILLION) 4.5 4.5 2.4 2.4 4.5 4.5 13.8 22.8DAILY DELIVERABLE DAILY DELIVERABLE CAPACITY 3.15 3.15 1.68 1.68 3.15 3.15 9.66 15.96

ANNUAL DELIVERABLE CAPACITY MILLION

742.5 742.5 396 396 742.5 742.5 2898 4788

NOTES : 3 shifts working P d d f l i di i i id f bl i /Bli i Products used as reference are only indicative to give idea of tablet size /Blister size. 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 CALCULATIONAdditional to above equipments/lines 3 coating machines are available : one 24"/30" interchangeable, one 60“ and 2 66” d i i 66” are proposed in expansion. Bulk packaging line which is capable of 120 bottles with a count of 100 tablets. Two 10 track strip packaging machines.

WET GRANULATION

LOT SIZEWG3- 30 KGSWG2 100 KGSWG2- 100 KGSWG1- 250 KGS WG 4 & 5 - 500 KGS * 2

BLENDING

LOT SIZEDG1- 350 OR 750 LITREWG2- 750 OR 1250 LITREDG2- 5000 LITRE

TABLET TABLET COMPRESSION

27 STATION DOUBLE ROTARY – 1 NOS

45 STATION DOUBLE ROTARY 3 NOS45 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. 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 tabletsAll compression lines are capable of compressing Bi-layered tablets

Provision for online tablet inspectionProvision for online tablet inspection

LEGEND 2500: CAPSULE FILLING MACHINE

Pellets + PowderPellets + Powder

Pellets + Micro TabletsPellets + Micro Tablets

SEVERAL FILLING COMBINATIONS:

Powder + Micro TabletsPowder + Micro Tablets

Capsule in CapsuleCapsule in Capsule

COATINGCOATING

26” / 32” DUAL- PAN AUTOCOATER 26” / 32” DUAL- PAN AUTOCOATER 26 / 32 DUAL- PAN AUTOCOATER 26 / 32 DUAL- PAN AUTOCOATER

60” AUTOCOATER - 1 NO60” AUTOCOATER - 1 NO

66” AUTOCOATER - 2 NOS

PACKAGING LINE - 11. 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 Ionized Air Jet Washing

Automatic Check Weigher Automatic cotton filling C S li Desiccant Insertion

Silica Gel Canister Inserter Electronic Counting & Filling

Cap Sealing Induction Sealing Machine Automatic Sticker labeling

PACKAGING LINES PACKAGING LINES – 2 , 3, 4

Three PAM’s BQS Model Capable of 450 BLISTERS/MIN onPVC - ALU and 280 BLISTERS/MIN on ALU – ALU

PACKAGING LINE 5PACKAGING LINE - 5ELMACH’s EPI 3020 BLITZ Model Capable ofupto 600 BLISTERS/MIN on PVC - ALU. This Machine is also capable of handling p gALU - ALU blisters

PACKAGING LINE – 6 & 7Two ELMACH’s EPI 2500 for handling gPVC - ALU has a rated output of 250 BLISTERS/MIN

PACKAGING LINE – 8 & 9 Two Strip packaging machines with capable of packaging approx 1 million

bl hiftablets a shift.

PACKAGING LINES FEATURESPACKAGING 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 semi automated cartoning.

All lines have check weighers.

Carton sealing and shrink wrap facility are also available Carton sealing and shrink wrap facility are also available.

Facility of barcode printing on shippers available.

PRIVATE LABELLING:

SECONDARY PACKAGING

BULK PACKING: BRANDED PRODUCTS

» Chillers with over 700 Tonnes of Refrigeration Capacity

B ild U Z t l ifi d id d ith ll C id t P iti » Build-Up Zones to classified areas are provided with all Corridors at Positive pressure compared to the Core Rooms.

» Over 50 AHU’s suitable for 50-55% Rh & in certain areas 40-45% Rh. Portable d h idifi il bl f f h d i i Rhdehumidifiers available for further reduction in 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 unitsthe facility and control all HVAC units.

» All Core areas – Class 100,000

» Micro lab – Class 10,000 & Class 1000

2000 liters per hour Purified Water Generation System

WATER SYSTEM

2000 liters per hour Purified Water Generation System.

Uses Reverse Osmosis & E D I systems.

3000 liters Storage Capacityg p y

Closed Loop Distribution Loop

Weekly Heat Sanitization programme.

In-house daily monitoring of water quality.

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

C bl f h dli DEVELOPMENT & MANUFACTURING P j » Capable of handling DEVELOPMENT & MANUFACTURING Projects.

» For Strategic Partners ; In-house API Production at our GMP Facilities is available to improve sustainability.

Hi h l l f A i & Ad Q li h k» High level of Automation & Adequate Quality checks

» Well Staffed Production, Engineering & Quality Teams headed by Qualified Personnel with Experience in Regulated Markets.

E t l C lt t d t i T i i d » External Consultants engaged to give Training and

Guidance on GMP.

» ‘Commitments’ with regards to Quality and Delivery.

» In-house Regulatory Affairs Team to support in

Dossier Compilation & Compliance.