Manufacturing Facilities
- GMP Manufacturing Plants
- WHO GMP Compliant
- Versatile Reaction Capability with Pilot Plants
- New Block designed to meet USFDA cGMP (under construction)
Manufacturing Reaction Capabilities
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Amino Methylation
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Esterification
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Bromination
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Grignard Reactions
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Catalytic Dehydrogenation
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Hydrogenation
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Chemical Reductions
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Hydrolysis Reactions
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Chlorination (by using Aq.HCl, SOCl2, POCl3)
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Mannich Reaction
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Cyclic Ring Cleavage Reactions
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Methylation
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Cyclization
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Mixed Anhydride Condensation
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Demethylation
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Oxidation
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Diazotization
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Phosphorylation
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Dry HCl Gas Reactions
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Utilities
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Boiler
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Chilling Plant (upto -15oC to -10oC)
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Cooling Tower
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High Vacuum System
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Oil Heating System (upto 250oC)
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R & D Centre
Expertise In
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Synthetic Organic Chemistry with focus on
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Non-infringing Process Development’
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Process Chemistry
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Process Engineering
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Well equipped, staffed to deliver
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New Products
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New Processes
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Technical Services
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Dry HCl Gas Reactions
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Ensures
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Smooth Technological Transfers
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Effective, Safe Environmental Technology
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Amino Methylation
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Bromination
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Catalytic Dehydrogenation
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Chemical Reductions
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Chlorination (by using Aq.HCl, SOCl2, POCl2)
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Chloro Methylation
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Cyclic Ring Cleavage
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Reactions
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Cyclization
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Demethylation
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Hydrolysis Reactions
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Diazotization
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Mannich Reaction
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Dry HCl Gas Reactions
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Methylation
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Esterification
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Mixed Anhydride Condensation
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Friedal-Crafts Alkylation & Acylation
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Nitration
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Gabriel Synthesis
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Oxidation
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Grignard Reactions
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Phosphorylation
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Hydrogenation
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Sulphonation
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R & D Centre - Reaction Capabilities
Patent Application Information
Granted PCT patent
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Published in March 2009
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Patent No.
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WO 2009/034580 A1
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Intl Publication date
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19-03-2009
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Product
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Risedronate Sodium Hemipentahydrate
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Field of Invention
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Improved Solvent Free Process for manufacturing
‘Risedronate Sodium’
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Advantages
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Better Safety to the Plant, Employees and totally Solvent Free
Higher Purity due to absence of solvent residues
Desired Crystalline Form
Significant Reduction in Process Time
Viable Commercial Feasibility
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QA System
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Recognized by ISO 9001:2000 Certification, a comprehensive standard covering all aspects of Quality Systems from production through delivery to the customers
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Multilevel QA System
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Latest on-line and laboratory testing equipments and instrumentation
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Systems backed up by continuous training of personnel
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Operates on the philosophy of ‘to do it right the first time, every time’ and also ‘zero error’
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Regular Internal Quality Audits by the QA to ensure our `Products & Services’ meet . Consistent , Specified and Recognized Level of Quality.
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QA
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Document Control
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Incoming Materials Control
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Calibrations
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In-Process Materials Control
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Customers’ Concern
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Process Control
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Training
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Process Change Control
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Preventive Maintenance
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Finished Goods Control
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Safety
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Traceability
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Audits
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Quality Control
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Regulatory Update
Full-fledge Regulatory Department with additional support of External Consultants
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ISO 9001:2000
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ISO 9001:2000 Certification No. 00947-2004-AQ-BOM- UKAS Dt. 02.07.2004 Assessed and registered by DNV (Det Norske Veritas) for meeting the requirements of ISO 9001:2000
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GMP
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GMP Certification from the Drug Control Administration, Government of Andhra Pradesh, India
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WHO GMP
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Applied for WHO GMP Certification
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USFDA
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New Block is designed to meet USFDA cGMP
(under construction)
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Technical / Regulatory Documents
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Buclizine HCl
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: DMF
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Carisoprodol
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: DMF
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Cinnarizine
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: DMF
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Cyclobenzaprine HCl
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: DMF
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Cyproheptadine HCl
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: DMF
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Etidronate Di Sodium
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: DMF
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Etodolac
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: DMF
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Flunarizine Di HCl
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: CEP
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Ketotifen Fumarate
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: DMF
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Loperamide HCl
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: DMF, (CEP)
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Meclizine HCl
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: DMF
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Oxatomide
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: (Tech. Pack), (DMF)
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Risedronate Sodium
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: DMF
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Tolterodine Tartarate
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: DMF
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( ) Parenthesis indicates under preparation
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QC Facilities
Well equipped with the latest testing apparatus and instruments to perform both Analytical Research & Quality Control tasks
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Gas Chromatograph
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IR Spectrophotometer
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UV Spectrophotometer
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HPLC/HPFC
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Polarimeter
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Auto Titrator
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Periodically Recalibrated Apparatus & Equipments and Revalidated Processes
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SOPs for Product Tracing and, in the unlikely event of a problem, Batch Recall and Investigation
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QC Testimonial
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Fleming Products Quality is evident from its satisfied Customers in about 70 Countries
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Environmental Protection & Safety Management
We are concerned about
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Environmental Protection & Safety Management
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Health and Safety of Employees
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