Dr. Santanu Ghosh

• Responsible for entire Technology development / Operation / setup on new plant and new R&D lab (as green field projects) / Renovation of Existing unit (as Brown field projects) / Taking care of one -USFDA Injectable plant operation ( Cephalosporin and Beta-lactaum)

• Responsible for entire Operation from Formulation development, Analytical Development and validation, Technology transfer, Bio study, Plant operation, Quality Assurance, Engineering and Regulatory affairs for EU and Emerging Markets.
• Handling green field projects of manufacturing plant having 12 manufacturing lines- from layout design to equipment’s instruments, Utility URS to FAT; now plant is under equipment’s installation stage.
• Responsible for setting up the new R&D to support complex generics and First file projects for regulated and Indian market for the following dosage forms: Solid Oral Dosage, Oral Liquid, Cream /ointment and gel products.
• Developing line extension products for Branded business and helping in troubleshooting scale up/manufacturing of complex.
• Also responsible to support Tech. Opts for site transfer of complex products and for scale-up, validation and launch of complex products.
• Successfully completed development of some generic and NDDS formulation development of which was going on since long, by providing technical inputs and using novel approaches to development.
• Trained formulators and analysts at the R&D w.r.t Quality-by-Design(QbD) and upgraded the development SOP and Product Development Report Template to incorporate QbD elements.
• Below activities have been completed successfully during my tenor-

- Designed and set up new R&D for product

development / Analytical development and Pilot

study.

- 14 manufacturing lines' equipment was selected

according to technology requirements; installation

and operation have started.

- Design and set up new QC lab for analysis /

Validation and micro analysis.

- 3 DCGI products First file activities had completed.

- 2 site transfer activities for EU have been completed,

another 6 products EU Site transfer products are

going on for Portugal union.

- 2 EU Generic projects development activities have

been completed and products are ready for TT.

- 10 generic products development activity has been

completed and transferred successfully to

Manufacturing unit with AMT / TT.

- 18 Products AMV have been completed successfully

and further 30 products development activity initiated.

• Was responsible for leading: (a) Hormone Plant – R&D and Plant Operation (b) Oncology R&D and Technology transfer ( As contract research ) (c) Oral Solid( General / Beta lactum) / Oral liquid / Ointment - R&D with Operation (d) Regulatory and site transfer projects of EU.
• Was responsible for leading and direction of all activities related product development for Europe, Canada, AU and Emerging markets that includes a wide range of therapeutic categories and drug delivery systems.
• The developments include vanilla generics and also complex projects (paragraph IV; Design around; Complex generics).
• Also responsible for leading the technology/site transfer of products from Indian R&D to Algeria and third party sites to India.
• Responsible for successful scale up to commercial scale and supporting product validation.
• Responsible for providing technical guidance to products being developed at external CROs.
• In General Oral Solid Dosage R&D Successfully submitted over 12 products in EU Market and 4 Products in AU and CANADA, 30 products for Emerging markets and 20 products improvised.
• 10 Oncology solid dosage formulation have been developed, optimized, exhibit batch prepared and successfully cleared 6 (BCS-class 2 and 4 drugs) products bioequivalence study and registered products in Algeria and 2 union of EU.
• 15 Hormone solid dosage formulation have been developed, optimized, exhibit batch prepared and successfully cleared 5 (BCS-class 2 and 4 drugs) products bioequivalence study and registered products in Emerging market.
• Successfully completed 8 site transfer projects of EU, 6 API facilities audited for EU, faced successfully 2 EU audits and 5 emerging markets audits.
• Introduced enhanced Quality-by-Design(QbD) concepts in development by introducing Design of Experiment (DoE) and Quality statistics.
• Also introduced new systems and procedures to improve the Data Integrity and Data Governance by forming a Data Integrity and Data Governance team in Analytical R&D and Formulation R&D.
• Successfully addressed a number of FDA deficiencies by providing sound technical inputs in a record time.
• Coordinating with procurement, Analytical, Costing, Marketing, Patent Cell Pharmacokinetics, Production for both New Products and Site Transfer; Budgeting and Budgetary control.

• Was responsible for leading : (a) R&D Operation (b) Manufacturing Plant Operation-Mfg / QA/ QC/Engineering/Supply chain / HR (c) Technology transfer (d) Regulatory and site transfer projects of Injectable.
• Was responsible for leading and direction of all activities related product development to entire manufacturing operations for Indonesia / Asian countries / Europe, Canada and AU markets that includes a wide range of therapeutic categories and drug delivery systems.
• The developments include vanilla generics and also complex projects (Design around; Complex generics).
• Also responsible for leading the technology/site transfer of products from R&D center to toll manufacturing facilities / third party sites to Indonesia.
• Responsible for successful scale up to commercial scale and supporting product validation.
• Responsible for providing technical guidance to products being developed at external CROs.
• In Oral Solid Dosage R&D Successfully submitted over +25 products in BPOM and 5 Products in Asian countries.
• The Sterile R&D submitted over 15 products to BPOM through successfully taken 3 batches from toll manufacturing facilities.
• Successfully commercialized 10 sterile products from toll manufacturing facilities at Indonesia and 8 products solid dosage formulation from own facilities.
• Successfully faced BPOM -GMP inspection, three Asian and one EU pre Audits.
• Introduced enhanced Quality- by-Design(QbD) concepts in development by introducing Design of Experiment (DoE) and Quality statistics and developed in house Subject Matter Experts (SME) for the same.
• Also introduced new systems and procedures to improve the Data Integrity and Data Governance by forming a Data Integrity and Data Governance team in Analytical R&D.
• Trained associates to have in-house subject matter experts (SMEs) for 'Stability Extrapolation' as per new FDA guidelines.
• Successfully addressed a number of BPOM (Indonesian FDA) deficiencies by providing sound technical inputs in a record time.
• Monitored three BCS Class -2 drug products bioequivalence study and submitted report to BPOM and 6 BCS class 1 and 3 BCS class -3 drug products bio waiver report submitted to BPOM and Asian (Malaysia / Singapore /Vietnam) and solve long time regulatory queries.
• Successfully completed development of 10 unstable generic products, the development of which was going on since long, by providing technical inputs and using novel approaches to development and submitted to BPOM.
• Coordinating with procurement, Analytical, Costing, Marketing, Patent Cell Pharmacokinetics, Production for both New Products and Site Transfer; Budgeting and Budgetary control.

• Was responsible for leading: (a) R&D (F&D and ADL) Operation (b) Manufacturing Plant Operation- Manufacturing difficulties / set up process / Process improvement (c) Technology transfer (d) Regulatory and site transfer projects.
• Leading the formulation development team of +20 Scientists, ADL +35scientists , Packing development 2 scientists ; Project Tracking and coordination (Technical) for New Product Development for Brazil , South Africa , Columbia, Venezuela , Peru and other Emerging Markets.
• Responsible for Site Transfer of Products from Peru to India facility; Project management of Contract Manufacturing Projects ; Coordinating with procurement, Analytical, Costing, Marketing, Patent Cell Pharmacokinetics, Production for both New Products and Site Transfer; Budgeting and Budgetary control.
• Was responsible for leading and direction of all activities related product development for all available markets that includes a wide range of therapeutic categories and drug delivery systems.
• The developments include vanilla generics and also complex projects (Design around; Complex generics).
• Also responsible for leading the technology/site transfer of products from Peru to India and third party sites to India.
• Responsible for successful scale up to commercial scale and supporting product validation.
• Responsible for providing technical guidance to products being developed at external CROs.
• In Oral Solid Dosage R&D Successfully submitted over + 60 generic products in Emerging markets.
• The Sterile R&D submitted over 30 generic products in emerging markets.
• Successfully faced 8 GMP inspection (WHO/ PERU –DIGIMED/ PICS pre audit etc ) and various client Audits.
• Introduced enhanced Quality-by-Design(QbD) concepts in development by introducing Design of Experiment (DoE).
• Also introduced new systems and procedures to improve the Data Integrity and Data Governance by forming a Data Integrity and Data Governance team in Analytical R&D.
• Introduced DQA (Developmental Quality Assurance) process in R&D.
• Successfully addressed a number of Various FDA deficiencies by providing sound technical inputs in a record time.
• Monitored twelve BCS Class -2 drug products bioequivalence study and submitted report to Emerging markets and 20 BCS class 1 and 13 BCS class -3 drug products bio waiver report, 6 DMF (Drug master file related) submitted to various drug regulatory bodies those are long time regulatory queries.
• Successfully completed development of 10 unstable generic products, the development of which was going on since long, by providing technical inputs and using novel approaches to development and submitted to various Regulatory agencies.
• One cold chain Local anesthetic product - Storage Vs efficacy VS potency calculation equivalency was established by Indicator and successfully marked.
• Process related development ….
• BCS class -2 drugs solubility increased by Hydrotrophy technique and formulated products and dissolution profile has been increased drastically.
• 12 different products RMG granulation process is converted by FBP (top spray) granulation process, which have reduced processing time and save energy and man power.
• Combine Lipophilic drugs - Hot melt extrusion technology will convert by wet granulation process and formulated stable product which is bio friendly.

• Was responsible for leading: (a) R&D (F&D and ADL) Operation (b) Manufacturing Plant Operation- Manufacturing difficulties / set up process / Process improvement (c) Technology transfer (d) Regulatory and site transfer projects of Brazil (e) Quality Assurance function.
• Focus on Specialty Products, including but not limited to - Injectable drug delivery, Inhalations, Ophthalmic, and Oral Solids.
• Products developed in a wide range of therapeutic areas including cephalosporin’s, Plenums, penicillin's and complex Emulsion based injection.
• Leading the formulation development team of +27 Scientists, ADL +32scientists.
• Project Tracking and coordination (Technical) for New Product Development for AU, Brazil, South Africa, Columbia, Asian, and other Emerging Markets with Domestic.
• Responsible for Site Transfer of Products from Brazil to India facility; Project management of Contract Manufacturing Projects; Coordinating with procurement, Analytical, Costing, Marketing, Patent Cell Pharmacokinetics, Production for both New Products and Site Transfer; Budgeting and Budgetary control.
• Was responsible for leading and direction of all activities related product development for all available markets that includes a wide range of therapeutic categories and drug delivery systems.
• The developments include vanilla generics and also complex projects (Design around; Complex generics).
• Also responsible for leading the technology/site transfer of products from Brazil to India (Aculife Site).
• Responsible for successful scale up to commercial scale and supporting product validation.
• Responsible for providing technical guidance to products being developed at external CROs.
• In Oral Solid Dosage R&D Successfully submitted over + 6 generic products in Emerging markets.
• The Sterile R&D (SVP, LVP, Nasal, Emulsion based and Iron based complexed Injection) submitted over 40+ generic products in AU, Brazil, South Africa, Columbia, Asian and emerging and Domestic markets.
• Successfully faced 13 GMP inspection (INVIMA /ANVISA /MALAVI –MOH / PICS pre audit etc ) and various client Audits.
• Successfully addressed a number of Various FDA deficiencies by providing sound technical inputs in a record time.
• Monitored 6 products Clinical end point study and submitted report to Brazil and all others Emerging markets those are long time regulatory demand.
• Successfully completed technology transfer of 40 sterile products from R&D to pilot and further Commercial scale.
• Successfully stabilized 13 IV products in 100 ml Bag and registered in Brazil and emerging market.
• 9 eye drops products in one-piece Plastic bottles (FFS) and registered in emerging market.
• First file in –reduced intensity of pain in One popular emulsion based products (change in carrier in emulsion) and with successful Clinical end point study launched products in Emerging and Domestic market.
• Amino acid liquid IV products stabilized (which have bottle to bottle color and potency variation problem) and register followed by marketing.

• Was responsible for leading: (a) R&D (F&D and ADL) Operation (b) Manufacturing Plant Operation- Manufacturing difficulties / set up process / Process improvement (c) Technology transfer (d) Regulatory affairs.
• Focus on Specialty Products, Oral Solid dosage formulation Modified / Sustained release / Immediate release), Injectable drug delivery, Oral Spray, Vaginal spray, Nasal spray, Ophthalmic, Oral liquid developed in a wide range of therapeutic areas including cephalosporin’s, Plenums, penicillin's and complex Emulsion based Eye drop.
• Leading the formulation development team of +25 Scientists, ADL +36 scientists.
• Project Tracking and coordination (Technical) for New Product Development for India (Fast file projects), PICS , USA ( Contract research ),South Africa, Asian, and other Emerging Markets.
• Responsible for toll manufacturing projects from Lincoln facility to Centaur Pharmaceutical facility at Pune (For Novartis) and Sovereign ( For Novertis) at Daman facility; Project management of Contract Manufacturing Projects; Coordinating with procurement, Analytical, Costing, Marketing, Patent Cell Pharmacokinetics, Production for both New Products and Site Transfer; Budgeting and Budgetary control.
• Successfully completed All formulations are approved by DCGI with NDAC body.
• One Conventional Immediate Release Analgesic product formulate as Global Patented Bilayer Immediate with sustained release tablet and activity changes to Analgesic with Anti-inflammatory with pulsatile release and activity proved by BA (Bio availability study), further confirmed by Post marketing surveillance study.
• Registered this product to various emerging countries.
• One NSAID injectable product reformulate with novel regulatory approved solubilizer keeping same strengths but quantity of aqueous solvent reduced by one third, which is painless.
• One Painful Oil based depot antimalarial injection reformulates to painless injection.
• Popular antiemetic solid formulations reformulate as Oral mouth melting strip and Oral spray which is increase the bioavailability and better absorption, proved by clinically.
• Both formulations are patented.
• One Popular Antifungal cream, reformulated as vaginal spray and clinically proved. It is also patented.
• Conventional, lipophilic fertility hormone reformulate as Vaginal spray (low dose) which is increase the absorption compare with oral dosage and injectable dosage formulation which is clinically proven. It is patented.
• Treat NVP (Treat Nausea and Vomiting, called Morning Sickness) combination drug immediate release formulation, converted to Sustained release formulation, which is taken care entire day with one dose.
• Further it is proved by clinical study.

• Was responsible for leading: (a) R&D (F&D and ADL) Operation (b) Manufacturing Plant Operation- Manufacturing difficulties / set up process / Process improvement (c) Technology transfer (d) Regulatory affairs (e) Site transfer projects of EU/UK.
• Focus on Specialty Products, Oral Solid dosage formulation Modified / Sustained release / Immediate release), Oral liquid, Cream /ointment and Gel developed in a wide range of therapeutic areas including penicillin's and general products.
• Leading the formulation development team of +15 Scientists, ADL +18 scientists.
• Project Tracking and coordination (Technical) for New Product Development for India (Fast file projects), PICS , EU, UK ( Contract research ), AU, South Africa, Asian, and other Emerging Markets.
• Responsible for site transfer projects from EU to Chennai ( India) facility; Project management of Contract Manufacturing Projects; Coordinating with procurement, Analytical, Costing, Marketing, Patent Cell Pharmacokinetics, Production for both New Products and Site Transfer; Budgeting and Budgetary control.
• Successfully completed All formulations are approved by DCGI with NDAC body.
• Betalactum combination made as Dispersible tablet, Mouth melting tablet and BCS Class –II /IV drugs absorption is enhanced which is proved by BA study.
• Immediate release, bitter tasted Analgesic tablet made as bitter taste masked dispersible Alelgesic tablet.
• In Oral Solid Dosage R&D Successfully submitted over + 80 generic products in Emerging markets including For EU/UK…. Contract development…..
• Successfully completed ten products development and with Bio report submitted to UK ( as national file) and same products given to AU client for filling.
• For Emerging market In Oral Solid Dosage R&D Successfully submitted over + 65 generic products in Emerging markets including 10 products cream and gels.
• Successfully faced 12 GMP inspection (WHO/ Zimbabwe / UKMHRA ( 2 times)/ TGA / WHO Geneva etc ) and various client Audits.
• Successfully addressed a number of Various FDA deficiencies by providing sound technical inputs in a record time.
• Monitored six BCS Class -2/4 drug products bioequivalence study and submitted report to Emerging markets and 15 BCS class 1 and 15 BCS class -3 drug products bio waiver report, 10 DMF (Drug master file related) submitted to various drug regulatory bodies those are long time regulatory queries.
• Successfully completed development of 10 unstable generic products, the development of which was going on since long, by providing technical inputs and using novel approaches to development and submitted to various Regulatory agencies.
• Reformulate and process optimization with reduced the manufacturing time of Combine Beta lactum Tablet product.
• Introduced Aqueous coating process of Betalactum product.
• Better Taste masked beta lactum dry suspension product formulate and manufactured.
• Successfully completed 60 + UK Site transfer activity.

• Leading the formulation development team of +17 Scientists and QC +20 analyst; Project Tracking and coordination (Technical) for New Product Development for Russia, Ukraine, CIS, India and other Emerging Markets; Responsible for Site Transfer of Products from Russia to India; Coordinating with procurement, Analytical, Costing, Marketing, Patent Cell Pharmacokinetics, Production for both New Products and Site Transfer; Budgeting and Budgetary control.
• Oral Solid Dosage / Topical dosage form / Oral liquid dosage form - R&D Successfully submitted over +40 products in CIS Market and 25 Products in India.
• 6 products site transfer activity monitored in that period.

• Was responsible for leading: Formulation R&D Oral Solid R&D with a total strength of ~50 Scientist.
• R&D Successfully submitted over +20 products in domestic Market including 8 first file products.
• 1 products site transfer activity monitored in that period.

• Was responsible for leading: Formulation R&D Oral Solid R&D/Topical R&D / Sterile R&D with a total strength of ~20 Scientist.
• Analytical R&D with a total strength of ~25 Scientist.
• Technology transfer, Site transfer work.
• R&D Successfully submitted over + 30 first file products for domestic Market with bio study which are including 15 products of Tablet and capsule; remaining are sterile / eye drops / Topical.
• + 60 Generic products successfully submitted.
• Successfully completed +38 products technology transfer activities of Fulford, USA to India (Mepro Topical facility).
• 20+ products quality has been successfully improved.
• Lab note book concept and other QMS related activity concept have been introduced in R&D.