A R R LI LIFE S E SCI CIENCES ENCES PR PRIV IVATE LIM IMIT ITED
CO COMPAN ANY PROFILE v Es Establ blished d in 1996… as Calcium Chloride de manufacturer (A R CHLORIDES) (A v Sh Shif ifted ed t to M Manufactu turin ing o of in 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 Ltd. In 2014; v Na Name Changed to A R LIFE SCIENCES PVT LTD (UNIT st De 2) 2)fr from 1 st 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.
DIRECT CTORS Fo Founder & Managing Director: Mr Mr. K. K. SUBBA RE 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 Mr. K. K. KRI 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
VI VISION To To be be a gl globa bal pl player er in in th the fi field of of Ph Pharmaceutic tical In Intermediates an and AP API’ I’s.
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 operations ons v Co Commitm tment co coupled with with de determ rmination, de dedi dication an and di discipline
PL PLANT ( T (UN UNIT-1) 1)
PL PLANT ( T (UN UNIT-2) 2)
KEY COMPANY PERS RSONNEL NAME NA Desig ignatio ion De Department Experi Ex rience K K .SUBBA RE REDDY Ma Managing Dir Direct ctor -- -- +30 +30 Ye Years K. K.KR KRISHNA Ex Executive Dir Direct ctor Overall ll +1 +10 Ye Years CH CHAITANYA Operations Op CH. SH CH SHYAMSU SUNDER ER HE HEAD – R& R&D R& R&D +20 +20 Years B. B. RAMI RED EDDY GM GM - Pla lant Production Pr +30 Years +30 K. BH K. BHASK SKAR RED EDDY HE HEAD - QA QA QA QA +1 +15 5 Years
EM EMPL PLOYEES EES LIST UN UNIT 1 UN UNIT 2 TO TOTAL EMPLOYEES 58 58 68 68 PRODUCT PR CTION 20 20 25 25 QU QUAL ALITY AS ASSUR URAN ANCE 06 06 05 05 QUAL QU 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
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
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)
INFRASTRUCT IN UCTUR URE UN UNIT 1 UN UNIT 2 5989.3 .30 Sq Sq. M . Meters 5466. 5466. Sq Sq. Meters TOTAL PLANT AREA TO 22 (GLRs Rs – 06 ; ; 32 (GLRs – 13 32 13 ; TOTAL No OF REACTO TO TORS SSR – 19 SSR 19) SSR R – 16 16) TO TOTAL REACTION VOLUME ~ 33 ~55K ~55KL 33 KL CA CAPACIT CITY
SITE A APPROVAL S STATUS TY TYPE OF OF Accre rediation UN UNIT 1 UNIT 2 UN Fa Factory License √ √ IS ISO 900 9001: 20 1: 2015 √ √ US USFDA √ --- JA JAPAN √ --- WHO O GMP --- √ GM GMP --- √ TS TSPCB CB √ √
WA WAREHOUSE (UNIT 1) WA WAREHOUSE - II II WA WAREHOUSE - I SA SAMPLI LING & DISP SPENSI SING AREA SO SOLVENT TANK
WA WAREHOUSE (UNIT 2)
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.
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.
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.
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
QU QUALI LITY Y CON ONTROL OL (UNIT 1) WE WET LAB CONTR CO TROL SAMPLE E ROOM HPLC L HP LAB GC GC LA LAB
Li List st of Major Ana naly lyti tical l Instr nstrum uments ents (U (UNIT T 1) Name of the Instrument Na 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
QU QUALI LITY Y CON ONTROL OL (UNIT 2) WE WET LAB CONTR CO TROL SAMPLE E ROOM HPLC L HP LAB GC GC LA LAB
List of Ma Li of Major A or Analyt lytical In l Instru ruments ( (UNIT 2 IT 2) Name of the Instrument Na 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
SP SPEC ECIFICATIONS Raw materials All raw materials used in the manufacturing process are tested as per pre- v defined & well established specifications and approved by QC. No raw materials are used in the process without approval from the Quality v Control department. Intermediate & Finished product Intermediates are tested and approved by QC as per release specifications. v Finished products are released to market by QA. v
List of Maj Li Major r Utilities Name of the Instrument Na UNIT UN T 1 UNIT UN T 2 BRINE Compressor 18 18 TR – 2 No No's 's & & 14 TR R -1 No No. & & 18 8 20 T TR – 1 No No. TR - 1No TR No. & . & 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
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)
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
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