SLIDE 1
A R R LI LIFE S E SCI CIENCES ENCES PR PRIV IVATE LIM IMIT ITED
SLIDE 2 CO COMPAN ANY PROFILE
v Es
Establ blished d in 1996… as Calcium Chloride de manufacturer (A (A R CHLORIDES)
v Sh
Shif ifted ed t to M Manufactu turin ing o
inter ermed edia iates es in in 2 2004.
v Na
Name Changed to A R LIFE SCIENCES PVT LTD in 2008 (U (Unit 1). ).
v Unit
it 2 Acquir ired Dym Dymes Ph Pharma rmachem Lt
v Na
Name Changed to A R LIFE SCIENCES PVT LTD (UNIT 2) 2)fr from 1st
st De
December 20 2016. 6.
v Lo
Locat ated in in Je Jeedim imetla, la, Hyderab abad ad
v Ma
Mainly manufacture Intermediates and API’s for ph pharm rmaceu ceutica cal u use e
v Ma
Major portion of business through gh contract ma manuf ufact cturi uring.
SLIDE 3 DIRECT CTORS
Fo Founder & Managing Director: Mr
REDDY
v Wo
Worked in Dr Reddy’s for almost 20 years since in incep eptio tion
v Lo
Looks af after the fin inan ancial ial sid ide. Ex Executive Director: Mr
KRISHNA CH CHAITANYA
v B
B Tech from Indi dian Institute of Technology (IIT) Roorkee an and Mas asters from Iowa a Stat ate Univ iversit ity, USA
v Ma
Marketing g and Overall operations
SLIDE 4 VI VISION
To To be be a gl globa bal pl player er in in th the fi field
Ph Pharmaceutic tical In Intermediates an and AP API’ I’s.
SLIDE 5 DRIVI VING FORCE CE
v Qu
Quality lity an and Se Service ce
v In
Innovation an and Re Research
v Strat
ategic Pa Partnerships
v Tr
Transparency In In op
v Co
Commitm tment co coupled with with de determ rmination, de dedi dication an and di discipline
SLIDE 6
PL PLANT ( T (UN UNIT-1) 1)
SLIDE 7
PL PLANT ( T (UN UNIT-2) 2)
SLIDE 8 NA NAME Desig ignatio ion De Department Ex Experi rience
K K .SUBBA RE REDDY Ma Managing Dir Direct ctor
+30 Ye Years K. K.KR KRISHNA CH CHAITANYA Ex Executive Dir Direct ctor Overall ll Op Operations +1 +10 Ye Years CH
SHYAMSU SUNDER ER HE HEAD – R& R&D R& R&D +20 +20 Years B.
EDDY GM GM - Pla lant Pr Production +30 +30 Years K.
BHASK SKAR RED EDDY HE HEAD - QA QA QA QA +1 +15 5 Years
KEY COMPANY PERS RSONNEL
SLIDE 9
EM EMPL PLOYEES EES LIST
UN UNIT 1 UN UNIT 2 TO TOTAL EMPLOYEES 58 58 68 68 PR PRODUCT CTION 20 20 25 25 QU QUAL ALITY AS ASSUR URAN ANCE 06 06 05 05 QU QUAL ALITY CON ONTROL OL 16 16 14 14 WA WAREHOUSE 04 04 03 03 MA MAIN INTE TENANCE 09 09 16 16 H R & & ADM DMIN 02 02 05 05 SA SAFETY & ENVIRONMENT 01 01
SLIDE 10
LI LIST ST O OF F FACILI LITIES (UN ES (UNIT 1 1)
¢ WA
WAREHOUSE – RA RAW MA MATE TERI RIAL & ENGINEERI RING
¢ AD
ADMIN
¢ QU
QUALI LITY B BLOCK ( K (QA QA & & QC QC)
¢ PR
PRODUCTION BLOCKS – 2 2
¢ ET
ETP with MEE. EE.
¢ UT
UTILITY AREA
¢ PR
PROCESS WATER SYSTEM
SLIDE 11
LI LIST ST O OF F FACILI LITIES (UN ES (UNIT 2 2)
¢ WA
WAREHOUSE – RA RAW MA MATE TERI RIAL & ENGINEERI RING
¢ AD
ADMIN
¢ QU
QUALI LITY B BLOCK ( K (QA QA & & QC QC)
¢ PR
PRODUCTION BLOCKS – 3
¢ On
One Dedi dicated d Bl Block to carry out High Pressure Re Reactions (Up Upto 32K 32Kg) g), Cr Cryoge genic Reactions s (Up Upto - -80 80 De Deg C) C) Available.
¢ CL
CLEAN ROOM M - 2 2
¢ ET
ETP
¢ UT
UTILITY AREA
¢ WATE
TER SYSTE TEM M (DM M WATE TER & PROCESS WATE TER)
SLIDE 12 IN INFRASTRUCT UCTUR URE
UN UNIT 1 UN UNIT 2 TO TOTAL PLANT AREA
5989.3 .30 Sq
. Meters
5466.
TO TOTAL No OF REACTO TORS
22 (GLRs Rs – 06 ; ; SSR R – 16 16)
32 32 (GLRs – 13 13 ; SSR SSR – 19 19)
TO TOTAL REACTION VOLUME CA CAPACIT CITY
~33
33 KL ~55K ~55KL
SLIDE 13 SITE A APPROVAL S STATUS
TY TYPE OF OF Accre rediation
UN UNIT 1 UN UNIT 2
Fa Factory License
√ √
IS ISO 900 9001: 20 1: 2015
√ √
US USFDA
√
JAPAN
√
O GMP
GM GMP
TS TSPCB CB
√ √
SLIDE 14 WA WAREHOUSE (UNIT 1)
WA WAREHOUSE - II II WA WAREHOUSE - I SA SAMPLI LING & DISP SPENSI SING AREA SO SOLVENT TANK
SLIDE 15
WA WAREHOUSE (UNIT 2)
SLIDE 16
WA WAREHOUSE
Ø Raw Materials handling is being controlled with adequately defined procedures. Ø Warehouse provides separate areas with respect to status of materials, viz., Under Test, Approved and Rejected and are stored at Appropriate Designated Areas. Ø Solvents received in Bulk are Stored at Solvent Tank Farm. Ø Liquid raw materials received in Drums is stored at Separate Area.
SLIDE 17
LIST T OF OF MAJOR OR PROD ODUCTI TION ON EQU QUIPMENT T (UNIT T 1)
PRODUCTIO ION B N BLOCK - 1: : REACTORS : 20 (GLR – 06; SSR – 14) – Capacity Min : 0.1 KL Max: 3.0 KL). CENTRIFUGE : 07 Capacity: 36” – 6 No's; 48” – 1 No. VTD : 01 Capacity : 24 TRAYS RCVD : 01 Capacity : 200 L TD : 05 Capacity : 48 TRAYS Multi Miller : 01 Capacity : 250 Kg/hr. PRODUCTIO ION B N BLOCK - 2: : REACTORS : 02 (SSR – 02 ) – Capacity : 1 KL. Dedicated for Hydrogenation and Workup.
SLIDE 18
LIST T OF OF MAJOR OR PROD ODUCTI TION ON EQU QUIPMENT T (UNIT T 2)
PRODUCTIO ION B N BLOCK – 1 ( (B B BLOCK): : REACTORS : 21 (GLR – 10; SSR – 11) – Capacity Min : 0.6 KL Max: 5.0 KL). CENTRIFUGE : 07 Capacity: 36” – 3 No's; 48” – 3 No. , 24” - 1No. VTD : 01 Capacity : 12 TRAYS RCVD : 01 Capacity : 500 L TD : 05 Capacity : 48 TRAYS – 4 No.s & 96 TRAYS – 1 No. PRODUCTIO ION B N BLOCK – 2 ( (C B BLOCK): : REACTORS : 06 (SSR – 06 ) – Capacity Min : 1.0 KL Max: 3.0 KL Dedicated for Hydrogenation and Workup.
SLIDE 19
LIST T OF OF MAJOR OR EQU QUIPMENT T CLEAN ROOM OOM - UNIT T 2
CL CLEA EAN ROOM M 1 &2: REACTORS : 05 (GLR – 02; SSR – 03) – Capacity Min : 0.25KL Max: 2.0KL). CENTRIFUGE : 02 Capacity: 36” RCVD : 01 Capacity : 350 L TD : 03 Capacity : 48 TRAYS VTD : 01 Capacity : 06 TRAYS SIFTER : 02 Capacity : 30” MULTI MILL : 02 Capacity : 01 No. 50 Kg & 01 No,: 250 Kg MICRONIZER : 02 Capacity : 5 Kg & 100 Kg
SLIDE 20 QU QUALI LITY Y CON ONTROL OL (UNIT 1)
WE WET LAB HP HPLC L LAB CO CONTR TROL SAMPLE E ROOM GC GC LA LAB
SLIDE 21 Na Name of the Instrument No No.s
HPLC with VWD detector (AGILENT) 01 HPLC with VWD detector (SHIMADZU) 01 GC with Liquid Injectors (SHIMADZU) 01 GC with Liquid Injectors (AGILENT) 01 UV Spectro Photometer (LAB INDIA) 01 MR Apparatus (POLMON) 01 TDS/Conductivity Meter (POLMON) 01 pH Merer (LAB INDIA) 01 KF Titrator (POLMON) 01 IR Moisture Analyzer (LCGC) 01
Li List st of Major Ana naly lyti tical l Instr nstrum uments ents (U (UNIT T 1)
SLIDE 22 QU QUALI LITY Y CON ONTROL OL (UNIT 2)
WE WET LAB HP HPLC L LAB CO CONTR TROL SAMPLE E ROOM GC GC LA LAB
SLIDE 23 Na Name of the Instrument No No.s
HPLC with VWD detector (AGILENT) 01 HPLC with VWD detector (SHIMADZU) 02 HPLC with RI detector (SHIMADZU) 01 GC with HEAD SPACE (SHIMADZU) 01 GC with Liquid Injectors (AGILENT) 01 UV Spectro Photometer (LAB INDIA) 01 MR Apparatus (POLMON) 01 TDS/Conductivity Meter (POLMON) 01
Li List of Ma
lytical In l Instru ruments ( (UNIT 2 IT 2)
SLIDE 24 SP SPEC ECIFICATIONS
Raw materials
v
All raw materials used in the manufacturing process are tested as per pre- defined & well established specifications and approved by QC.
v
No raw materials are used in the process without approval from the Quality Control department. Intermediate & Finished product
v
Intermediates are tested and approved by QC as per release specifications.
v
Finished products are released to market by QA.
SLIDE 25 Na Name of the Instrument
UN UNIT T 1 UN UNIT T 2
BRINE Compressor 18 18 TR – 2 No No's 's & & 20 T TR – 1 No No. 14 TR R -1 No
& 18 8 TR TR - 1No
. & 20 TR R - 1No No. BOIL BOILER 0.8 .8 M MT & T & 2.0 .0 MT MT 2.0 .0 MT MT DG DG SET 125 K KVA & & 2 250 K KVA 125 K KVA & & 2 250 K KVA
Li List of Maj Major r Utilities
SLIDE 26 QU QUALITY MANAGEMENT
v Documentation and Record controls v Review and approval of QMS procedures and documents v Validations v Change control Management v Vendor approval and evaluation v Testing of Raw materials, Intermediates and Finished products v Product Release v Handling of OOS and Deviations v Handling of customer complaints, product recalls and returns v Internal Audits v Stability Studies v Training v Annual Product (Quality) Reviews (AQRs)
SLIDE 27
RE RESE SEARCH & DEVELOPME MENT
Fu Fully Integrated & Qualified R&D Team of 11 Scientists
v Process Development of Intermediates & API’S v Characterization and Synthesizing of Impurities
Ke Key Initiatives of On site R&D team
v Cost Reduction & Quality Improvement v Technology Transfer from R&D to Plant (Scale up &
Validations)
v Troubleshooting v Customer support
SLIDE 28 RE REACTION CAPABILI LITIES
Grignard reactions
Hydrogenatio tion
Alkylation n reactions ns
Halogenatio tions reactio tions.
Oxidati ation re reac acti tions
Reduction reactions
Esterification
Hydrolysis is reactio tions
Conde densation r reactions
De-hy hydrogination re react actions.
Allylic br brom
react actions
Cyclization r reactions
Cryogenic r reactions
SLIDE 29 EN ENVIRONMEN ENT M MANAGEM GEMEN ENT (UN (UNIT 1 1)
v Seg
Segreg egatio tion o
Efflu luen ent
v High TDS and
d Low TDS
v Mu
Multiple Effect Evaporation System:
v Capacity: 20 KL/da
day
v So
Solid lid w waste: e:
v Solid
d waste will be be sent to State Approved d Solid d Waste di disposal Fa Facility.
v Sc
Scrubbin ing s system ems:
v Scrubbi
bbing systems are in place to ensure acidi dic vapors do do not enter int into atmo mosphere.
SLIDE 30 EN ENVIRONMEN ENT M MANAGEM GEMEN ENT (UN (UNIT 2 2)
v Seg
Segreg egatio tion o
Efflu luen ent
v High TDS and
d Low TDS
v So
Solid lid w waste: e:
v Solid
d waste will be be sent to State Approved d Solid d Waste di disposal Fa Facility.
v Sc
Scrubbin ing s system ems:
v Scrubbi
bbing systems are in place to ensure acidi dic vapors do do not enter int into atmo mosphere.
SLIDE 31
THANK YOU
