Symbiotica Specialty Ingredients - Research Development .

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SymbioticaSpeciality Ingredients Sdn. Bhd.Malaysia

SymbioticaSpeciality Ingredients Sdn. Bhd.M alay siaEstablished since 2001TextManufacturing Facility in Kulim, KedahFirst Regionally Owned Manufacturer of APIs in Malaysia and ASEAN

SymbioticaSpeciality Ingredients Sdn. Bhd.M alay siaCore ActivityResearch Development & Manufacture ofActive Pharmaceutical Ingredients

SymbioticaAccreditation, Certification and FilingsSpeciality Ingredients Sdn. Bhd.M alay siaPIC/S - ICH Q7A GMP CERTIFICATION - NPRA, MALAYSIAUS FDA- INSPECTED AND ACCEPTED FACILITYCOFEPRIS , MEXICO - GMP CERTIFICATIONEDQM CERTIFICATE OF SUITABILITY - 8 PRODUCTS, 2 UNDER EVALUATIONUS DMF - 8 FILED, 10 MORE BEING FILEDREPHINE, UK PHARMASSES GMPMNC - APPROVED SUPPLIERS TO GSK, SANOFI, TAKEDA, MYLAN, STADA, TEVAIS0 9001:2008 CERTIFICATION - BUREAU VERITAS CERTIFICATION

The BeginningsSymbioticaSpeciality Ingredients Sdn. Bhd.M alay sia-Period of Establishment.Development.Commercialisation ( 1 kg Batches ).2007 - 09 :-Export Excellence Award ( MITI - MATRADE ).Enterprise 50 awards - 6th Position ( SME corp - Delloite Malaysia).First CEP awarded from EDQM - for Dexamethasone Sodium Phosphate.More CEP applications - for additional produtcs began.2010 - 12 :-First Major expansion on existing site by addition of adjacent buildings, raising of work space heightScale up ( 20 kgs batches ).A separate facility for non-steroidal API was set up on the same site.Three major MNC supply audits and commercial contracts.US market developmental efforts - filing of US DMFs.Awarding of more CEPs.2013 - 17 :-First US FDA inspection took place by mid 2014 which was successful & entry into the USA marketCofepris GMP certified.New site of 15.14 acres was acquired at the nearby Kulim High Tech Park & additional industrial buildingsin Taman Industri Waja for the future growth strategy.Additional CEP filings and DMF compilations made.2000 - 01 :2002 - 03 :2004 - 06 :Pioneer status.Scale up ( 5 kgs Batches ).Expansion & upgrading works ( Grade D Cleanroom of class 100 K ).GMP certification - ICHQ7A-PIC/S and WHO.ISO Certification.First CEP application.

Symbiotica TodaySymbioticaSpeciality Ingredients Sdn.Bhd.M alay siaTurnover of USD 17 Million approx.Manufacturing nearly 40 APIs in batch sizes of1 kg - 100 kgs.85 % of revenue contributed by exports, one of the largest exporters from the MalaysianPharmaceutical Industry.Market presence in over 50 countries worldwide : Asia-pacific, Middle east, Russia, Balkans,Africa, Maghreb, Western EU, Eastern EU, North America, Central America, Latin America etc.GMP certified as per the ICH Q7 A guidelines by NPRA, Malaysia, a PIC/S member country,qualified to provide written confirmation as per new EC directive.Successfully inspected and accepted by the US FDA in July 2014.Cofepris GMP certified.Audited regularly by MNCs, EU clients, Independent EU audit agencies & other overseas clients.Hold 8 CEPs & filed 8 US DMFs.Winner of 2 awards – EXPORT EXCELLENCE from MITI & ENTERPRISE 50 from SME Corp.Regular participant in International Pharma fairs.Team of 80 people.

SymbioticaSpeciality Ingredients Sdn. Bhd.M alay siaPhilosophyBelieve in S ym bi osi s ,F unc t i on w i t h S pec i al i zat i on & S ynergy,D eliv er Ingredi ent s wi t h Qual i t y,Serve with Excellence,Live with passion !Make t he worl dH a ppy , H e a l t hy & l i v e l y ,as a Life Sciences C ompany.

SymbioticaSpeciality Ingredients Sdn. Bhd.M alay siaCore CompetenceQualityTr u s tServiceFlexibilityReliabilityCompetitiveness

SymbioticaQuality DepartmentQualityAssuranceQualityControlSpeciality Ingredients Sdn. Bhd.M alay siaValidationRegulatoryAffairs

SymbioticaSpeciality Ingredients Sdn. Bhd.Quality Management SystemM alay siaPharmaceutical Inspection Cooperation Scheme( P IC /S ) / IC H Q7ACertified byNational Pharmaceutical Regulatory AgencyMalaysiaIS O 9 001: 2008Certified byBureau Veritas Quality InternationalQMS managed and implemented through a 5 Step PlanInternal AuditCertificationAuditClient Audits/Vendor AuditsLocal RegulatoryAuditsInternationalRegulatoryAudit

Quality AssuranceSymbioticaSpeciality Ingredients Sdn. Bhd.M alay siaResponsible for Quality Management system and batch releaseEnsures Compliance towards ICH Q7A GMP & ISO 9001:2008Conducts Training & retraining to ensure that personnel follow SoPsEffects Surveillance audits to enforce QMS & GMPCarries out Annual Internal Audits & Management ReviewDocumentation preparation, implementation, review and control.Designs & implements procedures related to validation involvingprocess, cleaning procedures, equipment qualification, utility qualification.Regulatory document management in terms of preparation, submission,registration, review of Drug Master Files as well as responding to regulatoryqueries from regulatory authorities and customers.Approval, filing and review of change controls, deviations, CAPAs, etc.Management of Annual Product Review, Customer Complaints & Investigationwhen necessary.Issuance & Review of Batch Manufacturing Records.Preparation and maintenance of Master Protocol such as SoP list & ValidationProtocolManagement of Vendor Qualification.

SymbioticaFiling ofDrug Master filesCommon Technical DocumentsTechnical PacksRegulatoryAffairsUS DMFsRARARABETAMETHASONE SODIUM PHOSPHATECLOBETASOL PROPIONATEHYDROCORTISONE VALERATEMOMETASONE FUROATEEXEMESTANECEP/COSBETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEHALOBETASOL PROPIONATEM alay siaBETAMETHASONE VALERATEBETAMETHASONE VALERATEDEXAMETHASONE SODIUM PHOSPHATESpeciality Ingredients Sdn. Bhd.Registration withauthorities,Answering ofqueries ofauthorities &customersCLOBETASOL PROPIONATEDEXAMETHASONE SODIUM PHOSPHATEMOMETASONE FUROATEPREDNISOLONE ACETATETIBOLONEAPPLIED :EXEMESTANETESTOSTERONE PROPIONATE

Manufacturing Site - CurrentSymbioticaSpeciality Ingredients Sdn. Bhd.M alay siaSteroidal Block10 Mts/AnnumMultiproduct SiteNon-Steroidal BlockKulim, Kedah, Malaysia20 Mts/Annum

Manufacturing activitySymbioticaSpeciality Ingredients Sdn. Bhd.M alay siaFacility is spread over 27,000 sqft (2,500 m2 ) land area with 2separate manufacturing blocks for Steroidal and Non-Steroidal APIs.Centralized warehouse is located inside a separate building.Raw materials are subjected to quarantine, sampling & QC releaseprior to dispensing in separate and dedicated Down-Flow Booths priorto transfer forproduction.Production involves various chemical synthetic steps involving reaction, distillation, extraction,separation etc., which are carried out in the Crude Chemical area. This area is equipped withReactions Vessels made of Stainless Steel, Mild-Steel-Glass-Lined, Full-Glass, etc. Condensers,Centrifuges, Neutsche Filters, Sparkler Filter, Tray Dryers, etc.Final Powder Processing is carried out in a ISO Class 8 Clean-Roominvolving Drying, Milling, Micronization, Blending, Packing etc.Equipments used in this area are Tray Dryers, Vacuum Tray Dryers,Rotary Cone Vacuum Dryers, Blenders, Mills and Micronizers. Packing iscarried out only after final QA batch release. In-Process Quality Controlensures adherence to standard procedures for consistent Quality underGMP compliancePlant utilities involve Huber Temperature Control Systems, Chillers, NitrogenGenerator, Vacuum Pumps, DI water system, Scrubber, Evaporative VentilationSystems, Exhausts, Air-Handling Units etc.

SymbioticaFacility Layout519Speciality Ingredients Sdn. Bhd.M alay sia518517Non-SteroidalChemical AreaCentralized WarehouseNon-SteroidalPowderProcessing AreaQC-IntSteroidal Chemical AreaCommonZoneQC-WSteroidal PowderProcessing

Manufacturing SitesSymbioticaSpeciality Ingredients Sdn. Bhd.M alay siaSite I : CurrentAddress518, Jalan Waja 4, Taman Industri Waja, 09000, Kulim, KedahSize27,000 sftCertificationsNPRA - ICH Q7A : PIC/S GMP certification ( Last inspection - Sep’15 )US FDA - successfully inspected and accepted ( Last inspection - July’14 )Site II : New - Green FieldAddressLot 4, Industrial Zone Phase 2, Kulim Hi-tech Park, 09000, Kulim, KedahSize15.14 acres ( 659,498.4 sft )Certifications-

SymbioticaLocation of the the SitesSpeciality Ingredients Sdn.Bhd.M alay siaCurrent SiteNew Site

SymbioticaSpeciality Ingredients Sdn. Bhd.M alay siaSymbiotica - IIKulim Hitech industrial estateTargeted date of completion : End 201815.14 Acres / 612700 sqm / 659499 sqft

SymbioticaSpeciality Ingredients Sdn.Bhd.Proposed Activities at the New Green Field SiteSterile Steroidal API - Crystallized / LyophilizedNon-steroidal API BlockAdditional Steroidal & Hormonal API BlocksSteroid Intermediate BlocksFermentation BlockPhytochemical R&D and Industrial facilityM alay sia

Our ValuesSymbiosisCustomized solutions in terms of tailoringquality, packaging, sterilization, analysis etcto suit customer needs. Impurity .ReliabilityResponsible approach towards servicing ofclient’sregulatoryneeds,effective&empathetic handling of customer feedbacks,successfully undergoing audits with an open& transparent attitude, etc have contributedtowards a very strong factor of trust amongstclientele.SymbioticaSpeciality Ingredients Sdn.Bhd.M alay siaAssociate with a spirit of Symbiosis towardsmutually beneficial co-existence in allspheres - Internally & Externally CustomizationVery high level of reliability achieved throughPrompt responsiveness, Maintenance ofample inventory levels, Secure QMS, Timelydeliveries etc.Trustability

EpilogueSymbioticaSpeciality Ingredients Sdn.Bhd.An experiment that Metamorphosed to a rich & great experience.Challenges of operating an API manufacturing company inMalaysia have been successfully met.Global reputation as a major player in the steroidal API field andone of the few companies that produces Pinaverium Bromide( Non-steroidal API ).First Asian company to obtain CEP for Dexamethasone SodiumPhosphate – first one to get it after Sanofi and Pfizer.First Asian company to obtain CEP for Tibolone and the second inthe world after an Italian mfr.Approved supplier to major MNCs – GSK, Sanofi Aventis, Takeda,Mylan, Stada, TevaM alay sia

SymbioticaSpeciality Ingredients Sdn.Bhd.STEROIDSB EC LO ME T HASO NE D IP RO PI O NAT E *B ET AM ETA M ETHA S ONE A C ET A TEB ET AM ETHA SO NE DI P R OP IO NA T E * B ET AM ETHA SO NE SO DI UM P HOS PHAT E *B ET AM ETHA SO NE VA L ER A TE * B UDESO NI DEC L OBE T AS OL P R OP I ONAT E * C L OBE T AS ONE BUT Y R AT EC L OS T E BOL AC E T AT ED E F L AZAC O R TD E XAM E T H AS O NE S O D I UM P H O S P H AT E * D R O S P I R E NO NEE XE M E S T ANE * H AL O B E T AS O L P R O P I O NAT E H Y D R O C O R T I S O NE B U T Y R AT EH Y D R O C O R T I S O NE H E M I S U C C I NAT E *H Y D R O C O R T I S O NE V AL E R AT E M E T H Y L P R E D NI S O L O NE AC E P O NAT EM E T H Y L P R E D NI S O L O NE H E M I S U C C I NAT E *M O M E T AS O NE F U R O AT E * P R E D NI C AR B AT E *P R E D NI S O L O NE AC E T AT E *P R E D NI S O L O NE H E M I S U C C I NAT EP R E D NI S O L O NE P I V AL AT EP R E D NI S O L O NE S O D . M E T AS U L F O B E NZO AT EP R E D NI S O L O NE S O D I U M P H O S P H AT E *T E S T O S T E R O NE P R O P I O NAT ET I B O L O NE *M alay siaTextProducts withREGULATORY Package* CEP US DMF* CEP under applicationOthers – CTD availableCustomizations :MicronizationTerminal Sterilization :Gamma radiation @ 10-15 KGYDose

SymbioticaSpeciality Ingredients Sdn.Bhd.M alay siaSTEROIDSD I F L O R AS O NE D I AC E T AT ED E S O NI D ED E XAM E T H AS O NE D I M E T H Y L B UT Y R AT ED E XAM E T H AS O NE D I P R O P I O NAT ED E XAM E T H AS O NE I S O NI C O T I NAT ED E XAM E T H AS O NE P AL M I T AT ED E XAM E T H AS O NE P H E NY L P R O P I O NAT ED E XAM E T H AS O NE P I VAL AT ED E XAM E T H AS O NE S O D . M E T AS UL F O B E NZO AT ED E XAM E T H AS O NE VAL E R AT EF L U M E T H AS O NE P I V AL AT EF L U O C I NO NI D EH Y D R O C O R T I S O NE AC E P O NAT EH Y D R O C O R T I S O NE B U T Y R AT E P R O P I O NAT EM E T H Y L P R E D NI S O L O NE AC E T AT EP R E D NI S O L O NE V AL E R AT E AC E T AT ET R I AM C I NO L O NE AC E T O NI D ET R I AM C I NO L O NE D I AC E T AT ET R I AM C I NO L O NE H E XAAC E T O NI D ET R I L O S T ANEP roduc t s whi c h c a nbe upgraded t oREGULATORYP a c ka ge a ga i ns tc ommi t t e d proj e c t swit h pot ent ialpart nersCustomizations :MicronizationTerminal Sterilization :Gamma radiation @ 10-15 KGYDose

SymbioticaSpeciality Ingredients Sdn.Bhd.M alay siaNON-STEROIDSPINAVERIUM BROMIDESupported with REGULATORY Package in terms of aCTD format DMF ( ASMF, EDMF ). Audited byCOFEPRIS, Mexico.

SymbioticaSpeciality Ingredients Sdn. Bhd.US FDA - Products with DMF NumbersPRODUCTM alay siaUS DMF NO.BETAMETHASONE DIPROPIONATE24486BETAMETHASONE VALERATE27210CLOBETASOL PROPIONATE24015DEXAMETHASONE SODIUM PHOSPHATE24215EXEMESTANE25275HALOBETASOL PROPIONATE30906HYDROCORTISONE VALERATE31423MOMETASONE FUROATE26153

US FDA - NDC Listed productsPRODUCTNDC NO.Beclomethasone Dipropionate52128-128-01Betamethasone Acetate52128-131-01Betamethasone valerate52128-125-01Betamethsone Dipropionate52128-123-01Betamethsone Sodium phosphate52128-124-01Clobetasol ethasone Sodium asol propionate52128-138-01Hydrocortisone butryate52128-130-01Hydrocortisone valerate52128-136-01Methylprednisolone Aceponate52128-139-01MethylPrednisolone Acetate52128-148-01Mometasone Furoate52128-126-01Pinaverium solone Hemi Succinate52128-149-01Prednisolone sodium phosphate52128-127-01Testosterone olone Acetonide52128-143-01Triamcinolone diacetete52128-145-01Triamcinolone Hexacetonide52128-144-01SymbioticaSpeciality Ingredients Sdn. Bhd.M alay sia

SymbioticaEDQM - Product/CEP NumbersPRODUCTSpeciality Ingredients Sdn. Bhd.M alay siaCEP / COS NO.BETAMETHASONE DIPROPIONATER0-CEP 2011-005-Rev 00BETAMETHASONE SODIUM PHOSPHATER0-CEP-2013-326-Rev 00BETAMETHASONE VALERATER1-CEP 2008-215-Rev 00CLOBETASOL PROPIONATER1-CEP 2009-221-Rev 00DEXAMETHASONE SODIUM PHOSPHATER1-CEP 2006-184-Rev 00MOMETASONE FUROATER1-CEP 2009-313-Rev 00PREDNISOLONE ACETATER0-CEP-2014-138-REV 00TIBOLONER1-CEP 2010-294-Rev 00

SymbioticaSpeciality Ingredients Sdn. Bhd.M alay siaThank you

symbiotica speciality ingredients sdn. bhd. malaysia pic/s - ich q7a gmp certification - npra, malaysia us fda - inspected and accepted facility cofepris, mexico - gmp certification edqm certificate of suitability - 8 products, 2 under evaluation us dmf - 8 filed, 10 more being filed rephine, uk pharmasses gmp mnc - approved suppliers to gsk, sanofi, takeda, mylan, stada, teva

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