CALYX specializes in manufacture of Active Pharmaceutical Ingredients and fine Chemical Intermediates. CALYX meets International quality standards and have earned clients across the world.

Product line includes Antibiotics, Anti-TB and Hypnotic Actives as well as a wide range of Intermediates.

Production facilities are in two separate locations and consist of 4 discrete plants. Each is designed to service a group of processes.

CALYX offers products meeting US FDA, EDMF and COS as well as WHO cGMP standards. Our Plant Hygiene, strict implementing of SOP's and consistent quality make us an unique, reliable but competitive vendor.Calyx Calyx Calyx Calyx Calyx

Calyx Calyx Calyx Calyx Calyx Certification

Pyrazinamide

-------------------------------------------------1. COS Reg. No. - RO-CEP 2000-036.Rev 01 2. WHO GMP Reg. No. - WHO/GMP/CERT/KD/21 3. USDMF 155534. EDMF Approval awaited 5. Russian Registration Applied

Zopiclone

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1. COS RD-CEP 2001-203-Rev 002. WHOGMP Applied 3. USFDA DMF No. - 15518 4. Russian Registration Applied

Certificate of Suitability

CALYX CHEMICALS & PHARMACEUTICALS PVT LTD

Founded in 1979 , Calyx Chemicals & Pharmaceuticals Pvt Ltd, is a fast growing Bulk Drugs company , manufacturing Active Pharmaceutical Ingredients and Intermediates that meet US-FDA certificated suitability, cGMP & many other individual country standards.

We back all our clients with a professional & qualified R & D organization that at present consists of highly experienced scientists & a dynamic Responsive Management Team. Calyx R&D facilities are located at Dombivli(Maharashtra).

We invest in State-of-the-art equipment that deliver the best Results. Our API Plants are located at Tarapur & our intermediate manufacturing facilities located in dombivli both (near Mumbai-Maharashtra). Soon we will have additional manufacturing facilities in Mahad(Maharashtra). We do not offer Placement but provide excellent Opportunities & Excitement for R&D Scientists who have the desire & will to continually challenge themselves to become associated with a research driven new age drug organization.

Our Associate would be Phd or Msc in Organic Chemistry. Experience in Bulk drug industry with ability to take on the challenges of process development of new generation molecules will certainly be an added advantage.

Do look us up at hrd@calyxindia.com soonest. We assure you immediate Response.

Calyx Chemicals & Pharmaceuticals Pvt. Ltd.5, Marwah's ComplexSaki-Vihar RoadSaki-NakaAndheri (E)Mumbai - 400072India

Tel : 91-22-285 75 037Fax : 91-22-285 75 036

e-mail : calyx@calyxindia.com

A stand-alone R&D facility 40 scientists for process development 10 scientists for analytical method development Technology transfer team Ability to develop multi-step synthesis Pilot plant facility - gm and kg level Standard analytical facilities: GC, HPLC, FTIR, UV Spectrophotometer etc.

Alkylation Acylation Ammonolysis Cyclocondensation Esterification Friedel-Craft Reaction Reduction/Hydrogenation Hydrolysis Halogenation Knoevnagel Reaction Mannich Reaction Mesylation Optical Resolution Oxidation Tosylation Eschweiler-Clarke Reaction (Formylation/Reductive Alkylation)

Calyx International, LLC.

PMB 4132 * 197 Route 18 South, Suite 3000East Bruunswick, New Jersey 08816

Tel : 732-238-7799Fax : 732-651-7573

e-mail : sales@calyxusa.comExperienced Regulatory Team Many DMFs and COS Latest analytical tools: GC, HPLC, FTIR, Spectrophotometer ICH stability facility Standardized testing: Chemical, Instrumental, Microbiological analysis MFR, BMR & Validation records Stability test SOP CALYX operates two multipurpose production facilities located at Tarapur & Dombivli : Which are within driving distance from Mumbai. Our plants employ State-of-the-art technology coupled with high degree of automation.

The actual synthesis, isolation and purification of our products is housed in a two storey building designed specifically for the purpose and is constructed of reinforced concrete. All used materials ensure freedom from corrosion. The walls and the flooring inside the production areas are coated with food grade U.V. resistant paints, epoxy flooring and protectives that do not permit any transfer of matter through its membrane.

This coating is acid / alkali / solvent resistant and it does not allow any accumulation of particles on its surface. The quality of air supply into the production area is suitable for the production of pharmaceutical products and is regularly monitored. Man and material movement is designed to ensure that there is no back tracking. The entire plant layout has been evolved to ensure meeting of all safety standards.

PROCESS

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EQUIPMENT SPECIFICATION S.S.Reactor (3 Nos) 7000 Ltrs. with distilation facility S.S.Reactor (3 Nos) 3000 Ltrs. with distillation facility Glass Lined Reactors 5000 Ltrs. & 3000 Ltrs. with distilation facility Crystallizers (3 Nos.) 7000 Ltrs. Sparkler Filters 33" Dia - 15 Nos14" Dia - 10 Nos. Centrifuges 48" Dia SS 316 No.336" Dia SS 316 No.1 Blenders 1400 ltrs ( SS 316 ) Fluid Bed Dryer 200 Kgs.( GMP MODEL ) Multimill Pneumatic feed system (SS316) ML Storage Tank 5000 Ltrs. / 10000 Ltrs. Scrubber 1000 cfu / min Effluent Treatment Plant Neutralization,Filtration & Aeration.

UTILITIES

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EQUIPMENT SPECIFICATION

Steam Boiler (4 nos) 600 kg/hr Compressed Air 110 CFM, Non lubricant Chilling Plant 32 TR at -10癱 Cooling Tower 150 TR Power 500 KVA Transformer Tank Farm Furnace Oil Weighing Scales Electromechanical (500 kgs)Electronic Balance (60 kgs) AHU

3 micron 25000 CFM with 5 air changes per hour5 micron 30000 CFM with 15 air changes per hour DM Plant with UV system 6000 Ltrs. per hour Power Back Up 380 KVA

Quality Assurance :

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Our team is committed to consistent quality, continuous & enhanced process capability, zero customer complaints,zero accidents, safe enviorment & continuous improvement in products, processes & quality systems.

n Well equipped laboratory. n Qualified & experienced staff. n Documentation of MFR,BMR,SOPs,Methods & Specifation as per cGMP Standards. n Validation of water & air system, equipment & processes. n In process checks.

n Product study for impurity profile,stability (Real Time & Accelerated), degradation, development chemistry, residual solvent analysis. n cleaning validation after product change over. n Periodical training program. n Internal audits.

Safety, Health & Environment :

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Safety of people overrides every other saftey concern.

Electricals : Consealed cabeling with FLP motors & switches and double casting.

Disaster Management: Fire fighting,Flooding & other Calamities,provision of fire dampers for AHU,lightening arrestors.

Design of plant &equipment :Provision for pressure & temperature control ,safety valves,,flame arrestor,rupture discs,proper venting. Adequate provision of fire fighting equipment. Provision of fire wall and fire proof doors. Separate entry & exit. Adequate enviorment control.

UNDER CONSTRUCTION