sonia organics
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SONIA ORGANICS
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SONIA ORGANICS
Introduction
• Sonia Organics was established and started operations in the year 2007
• Developers and manufacturers of pharmaceutical products specializing in Active Pharmaceutical Ingredients, Intermediates, Specialty
Chemicals and Nutraceutical products
• We are well recognised as a ‘Partner of Choice’ by leading pharma companies worldwide
• Manufacturing Facilities, located in Karnataka, are approved by local FDA authority
• Well-equipped Semi-automated manufacturing plants with a combined capacity of 80KL
• Cost Effective Manufacturing practices capable of producing 7-8MT of output monthly
• Certified Class one lakh GMP facility having two independent lines
• ISO 9001:2015 certified facilities with quality systems complying to ICH-Q7 guidelines
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SONIA ORGANICS
Our Group of Companies:
Unit - 1
Since 2007Unit - 2
Since 2019
Greenfield
Project
Mundra EnterpriseTraders of Pharmaceutical &
Nutraceutical Products
Since 3 Decades
Natural Capsules LimitedManufacturers of Gelatin Capsules
Unit - 1 Bangalore, Karnataka
Unit - 2 Pondicherry, Tamil Nadu
Since 3 Decades
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Vision & Mission
Vision:
Mission:
• Continuously manufacture quality pharmaceutical products
• Establishing and maintaining customer relationships by providing novel manufacturing
and research services
• Create value by investing in research and development of new products and
technologies
• Invest in human resource development through training mentoring and empowering
To be recognized as a world-renowned manufacturer of APIs, intermediates and specialty
chemicals by all our stakeholders
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Core Values:
Integrity
Reliability Quality
TeamworkInnovation
• Led by a dedicated and experienced management team that has a median of 20 years of experience across global pharmaceutical and life
sciences industries
• The team is filled with Chemical Engineers, PhD’s, Quality and Regulatory experts that have more than 15 years of experience individually
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Key Personnel:
Team:
• Sushil Mundra – Founder & Managing Partner
• Durairajah – Chief Operating Officer
• Kaushal Kumar Jha – GM Production
• Venkatesh Rao – Quality Assurance & Regulatory
• Arun Setty – Quality Control
• Madhav Mundra – Finance & Analytics
PhDs & ChemistsManagement &
Commercial MembersRegulatory Experts
Scientific to Non-Scientific Staff
70%:30%
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Lab
DevelopmentOptimization Validation Documentation
• Test License
• Lab feasibility
• IPR clearance
• Sample preparation
• Indicative Stability
• Optimization & VQ
• Risk assessment &
HAZOP Studies
• GI Evaluation
• Process Optimization
• Lab Validations
• Batch Size Finalization
• Pilot Batch Trial
• Method Validation
• Validation batches
• Stability Study
• DMF Docs Readiness
• Filing with 3M Stability
• Commercialization
• Tech Transfer & PDRs
Our Process Approach:
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Competencies:
Contract Manufacturing
(CMO)
&
Custom Development
Manufacturing (CDMO)
We offer services such as:
• Lab Assessment, Process Optimization and Stabilization, Scale-up & Commercial Manufacturing
• Analytical Research & Development
• In-process and Final Release Testing
Reaction Capabilities:
• Grignard reaction
• Fridel Craft Reaction
• Chiral Synthesis
• Hydrogenations at pressures ( up to
10 Kg (150 psi) pressure)
• Selective reduction
• Halogenation
• High Temperature reactions ( 200°C
to +220°C)
• High Acidic Reaction
• High Vacuum Distillation
• C-C bond reactions
• Hazardous chemistry (Nitration,
POCl3 and BBr3 reactions)
• Cryogenic reaction (-80°C ) with n-
BuLi, LDA and Li-HMD
• Reductions using metal hydrides
(LAH, Red-Al, Superhydride,
LiBH4, etc.)
• Synthesis of Complex
Molecules/Targets – Multistep
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Manufacturing Unit-I: Accreditations
Location
• Attibele Industrial Area, Karnataka
• 62.5kms away from the Bangalore International Airport, 2kms away from the
National Highway NH48, 325kms away from the Chennai Seaport
Facilities:
• Three Production Blocks (A,B & C) with reactor capacities varying from 630 L to
5000 L having both Glass Lined and Stainless-Steel Reactors
• 2 GMP Lines with dedicated AHU for each line
• Total Reactor Volume of 60KL
• Analytical & Quality Control Lab equipped with HPLCs, GCs with head space,
Auto titrators, UV, IR complying with the L1 requirements of FDA
• Equipped with:
• R&D Lab with a dedicated Analytical R&D
• 2Ton IBR Boiler
• 27.5TR Chilling plant
• All Glass Pilot Plants - 20L to 100L capacity
• DM Water System
• Jet, Water Ring, Oil Ring Vacuum Systems
• Jet Milling (Micronizer 50 kg capacity)
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Site Map Manufacturing Unit-I:
Facilities:
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Manufacturing Unit-II: Accreditations
Location
• Harohalli Industrial Area, Karnataka
• 45 kms from Bangalore City and 140 kms away from the Bangalore
International Airport
Facilities:
• Two Production Blocks (A & B) with reactor capacities varying from 1KL to
6KL having both Glass Lined and Stainless-Steel Reactors
• Total Reactor Volume of 20KL
• Equipped with:
• QC Lab
• 2.5 Ton IBR Boiler
• 30TR Chilling plant
• RO Water System
• Jet, Water Ring, Oil Ring Vacuum Systems
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Site Map Manufacturing Unit-II:
Facilities:
Proposed Site 2 Layout with portion surrounded with the red boxes already constructed and commissioned
• 07, 08 – GMP Block (D,E)
• 09 – Warehouse (RM & FG), Kilo Labs
• 10 – Admin Block
• 11 – R&D Lab, QA Lab, QC Lab
• 12 – Canteen/Changin Area
• 13 – DG
• 14 – Transformer
• 15 – Security Block & Waiting Rooms
• 01 - Production Block A
• 02 - Production Block B
• 03 – Utility Block (Chilling Plant, Water Plant)
• 04 – 2.5T Boiler
• 05 – Effluent Treatment, Storage and Disposal
Area
• 06 – Solvent Yard
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040506
0708
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Quality Statement:
• We are committed to the delivery of safe and effective products to our customers, a
fundamental element of our mission
• To meet this commitment, we maintain a quality-focused culture to ensure the highest priority
is placed on the safety, efficacy and reliability of our products, the quality of data supporting
regulatory submissions, and interactions with our stakeholders
• We stringently adhere to implementing Quality Management Systems and are committed
towards making continual improvements to the same
Quality Assurance Quality Control Regulatory Affairs
Quality Assurance plays a key role in
maintaining the effective quality
compliance by staging various
pharmaceutical cGMP functions
through QMS, TQM, training,
effective documentation with
traceability.
Quality Control ensures the delivery
of high standard products that comply
with the required regulatory and
cGMP norms. QC, as a center of
excellence, ensures compliance and
follows systematic interventions
Regulatory Affairs personnel play a
crucial in assuring that all our
products are compliant with
regulations governing the industry
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Products:Active Pharmaceutical Ingredients:
Active Pharmaceutical Ingredients: Under Development
Sl No. Product Name CAS no. Therapeutic category Stage
1 Benfotiamine 22457-89-2 Antidiabetic Commercial
2 Clotrimazole 23593-75-1 Anitfungal Commercial
3 Ondansetron Hydrochloride 103639-04-9 Antiemetic, Antideprebetaant Commercial
4 Ondansetron Base 99614-02-5 Antiemetic, Antideprebetaant Commercial
5 Dextromethorphan Hydrobromide 6700-34-1 Antidepressant, Antitussive Commercial
6 Minoxidil 38304-91-5 Antihypertensive Commercial
7 Minoxidil Sulphate 83701-22-8 Antihypertensive Commercial
8 Misoprostol 1% HPMC 59122-46-2 Antiulcerative Commercial
9 Valgancyclovir Hydrochloride 178865-59-5 Antiviral Commercial
10 Calcium Dobesylate Monohydrate 11755-78-0 Diabetic Retinopathy Commercial
11 Thaimine Hydrochloride 67-03-8 Vitamin B1 Supplements Commercial
Sl No. Product Name CAS no. Therapeutic category Stage
1 Citicoline 33818-15-4 AntiParkinsons, Neuroprotector R&D - Sample Ready
2 Pregabalin 148553-50-8 Antiepileptic R&D - Sample Ready
3 Cetirizine Di Hydrochloride 83881-51-0 Antihistamines R&D - Sample Ready
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Products:Pharmaceutical Intermediates:
Specialty Chemicals
Sl No. Product Name CAS no. Final API Stage
1 2,4-Diamino-6-chloropyrimidine 156-83-2 Minoxidil Commercial
2 2-AminoDiphenylSufide 1134-94-7 Quetiapine Commercial
3 2-Chloro-6,7-dimethoxyquinazolin-4-amine 216699-86-4 Alfuzosin/Prazosin Commercial
5 Thiamine Monophosphate 10023-48-0 Benfotiamine Commercial
6 2-chlorophenyl Diphenyl Chloromethane 42074-68-0 Clotrimazole Commercial
7 R)-(-)-3-Carbamoymethyl-5-methylhexanoic Acid 181289-33-8 Pregabalin R&D - Sample Ready
8 3-Carbamoymethyl-5-methylhexanoic Acid 181289-15-6 Pregabalin R&D - Sample Ready
9 6-Fluoro-3,4-dihydro-(2H)-1-benzopyran-2-carboxylic Acid Ethyl Ester 99199-61-8 Nebivolol R&D - Sample Ready
10 5-Methyl Isoxazole-4-Carboxylic Acid 42831-50-5 Teriflunomide Commercial
Sl No. Product Name Cas No. Stage
1 2-Hexanone 591-78-6 Commercial
2 Phthaloyl Chloride 88-95-9 Commercial
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Environmental, Health & Safety:
We are committed to high standards and continual improvement in the areas of Environment,
Health & Safety (EHS)
Our Safety Committee engages in:
• Devising and Implementing EHS SOPs
• Review of safety performance and safety audit investigation of any incident and taking
necessary corrective and preventive action
• Safety is of the utmost importance to us; therefore, we organize and schedule safety &
operational trainings to all the necessary personnel along with organizing mock drills.
We conduct routine audits on:
• Chemistry Labs
• Hazardous areas
• Night safety
• Fire safety systems
We ensure proper segregation and disposal of harmful chemicals and materials by implementing
SOPs for hazardous chemical waste management. We have installed adequate ventilation &
suitable scrubbing systems to handle perilous reactions. We have initiated CSR activities in the
surrounding villages regarding Health & Education activities.
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Key Partners:
SONIA ORGANICS
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Gallery:
630L SS Reactor –
Unit 1
24” SS Centrifuge
– Unit 12000 sq. ft. Raw Material
Warehouse – Unit 1Wet Lab – Unit 1
GMP Block – Unit 1Production Block A –
Unit 2
QC Lab – Unit 1 Green Belt – Unit 1
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Corporate Office:
71, Ajay Arcade 2nd Floor,
VaniVilas Road, Basavanagudi,
Bangalore, Karnataka - 560 004
Ph: 080 – 26607697/+919538454135
Email: [email protected]
Website: www.soniaorganics.in
Manufacturing Unit-I:
Plot No.11/2 & 49/1,
KIADB Industrial Area,
Attibele Hubli, Balagaranahalli,
Anekal Taluk, Bangalore
Karnataka - 562 107
Manufacturing Unit-II:
PLOT NO: 69 TO 72,
Harohalli – KIADB –Phase-1-Industrial Area,
Kanakapura Taluk, Bangalore
Karnataka – 562 112
Thank you!