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Sunday, 15 February 2015

Dr. Swapnil Sonawane





Dr. Swapnil Sonawane

Associate director API R & D at DR REDDYS LABORATORY

Previous
  1. Piramal, Emcure Pharmaceuticals Limited
  2. Lupin Pharmaceuticals Ltd Pune



links


Posses strong understanding of API manufacturing (Oncology, Non oncology API's), formulation requirement at various phases of development. 

Specialized in synthetic organic chemistry with expertise in design of non-infringing, cost effective, scalable and safe synthetic route in line with QbD.

Expertise in process research along with ability to collaborate with cross-functional teams in R&D and manufacturing and compliance.

Generating standard scientific documents related to pre-and post product development phases.

Review and response to queries from various regulatory agencies.

Practicing and implementing GLP, GMP and SHE policies.

Turning around the business, customer development and retention for entering emerging markets and new business applications.

Patent infringement analysis and patent writing.

Patents
I) U. S Patent US 7777056, ~ EP 1732912 (B1)
Method for Manufacture of 4-Hydroxy Pyran-2-One
Derivatives. October, 2008.
II) 1776/MUM/2008
A Method Of Preparing Trans-4-Amino-1-Cyclohexane
Carboxylic Acid Derivatives
III) 655/MUM/2010
Novel process for antipsychotic API’s
IV) U. S Patent US 2011105598
Process for Preparation of Taxane Derivative
V) 3243/MUM/2011
Improved process for Fludarabine
VI) 3664/MUM/2011
Improved synthesis of Raltegravir

Specialties: 

Expertise in redesigning systems, processes, and products to reduce costs and increase efficiency.Turning around the business, customer development and retention for entering emerging markets and new business applications. 
Generic R & D of low volume high cost API (Antineoplastins), ARV's.

Experience 

Associate Director API R & D



Dr. Reddy's Laboratories
 – Present Hyderabad Area, India


 

 

 

API R & D

Piramal Enterprises Limited
   (4 months)Goregaon; Mum

Vice President R & D; Technical                                         






Trichem Lifesciences Ltd
 – JULU15Trichem Life Sciences



Principal Scientist API R &D (DGM)

Emcure Pharmaceuticals Limited
 –  (10 years 4 months)






Principal Scientist, API R&D (Generic-Oncology)

Emcure Pharmaceuticals Limited
 –  (10 years 4 months)
Working as team leader.





Research Scientist

Lupin Pharmaceuticals Ltd Pune
 –  (3 years 5 months)
Worked in API-Generic as a Research Scientist


Education

University of Pune


Ph D, Chemistry

Pune University



 

 

Publications


Short and Efficient Process for the Synthesis of trans-4-Aminocyclohexanecarboxylic Acid Derivatives(Link)

Org. Process Res. Dev
October 14, 2009
This contribution relates to an industrially feasible process for the preparation of isomerically pure trans-4-amino-1-cyclohexanecarboxylic acid derivatives that are useful building blocks in the synthesis of several pharmacologically active compounds

API R & D Centre, Emcure Pharmaceuticals Ltd., ITBT Park, Phase-II, MIDC, Hinjewadi, Pune - 411057, India
Org. Process Res. Dev.200913 (6), pp 1141–1144
DOI: 10.1021/op900195w

Abstract Image
This contribution relates to an industrially feasible process for the preparation of isomerically pure trans-4-amino-1-cyclohexanecarboxylic acid derivatives that are useful building blocks in the synthesis of several pharmacologically active compounds such as glimepiride, L-370518.



A Novel Method for Resolution of Amlodipine(Link)

Org. Process Res. Dev
March 12, 2010
The present invention relates to an industrially feasible and cost-efficient process for the preparation of isomerically pure S-amlodipine besylate hemipentahydrate (1), a useful calcium antagonist inhibitor.
http://pubs.acs.org/doi/abs/10.1021/op900283z
API R&D Centre, Emcure Pharmaceuticals Ltd., ITBT Park, Phase-II, MIDC, Hinjewadi, Pune-411057, India
Org. Process Res. Dev.201014 (3), pp 640–643
DOI: 10.1021/op900283z

Abstract Image
The present invention relates to an industrially feasible and cost-efficient process for the preparation of isomerically pure S-amlodipine besylate hemipentahydrate (1), a useful calcium antagonist inhibitor. Previous workers reported that R-amlodipine-tartrate was crystallized out preferentially from the reaction mixture when naturally occurring l-tartaric acid and racemic amlodipine base in DMSO are mixed. In order to crystallize S-amlodipine-tartrate, the use of unnatural d-tartaric acid as a resolving agent in DMSO was required. However, the cost of d-tartaric acid was not conducive to overall cost efficiency in the resolution protocol. Subsequent to the above observations, we have developed a novel resolving system in which amlodipine base with natural l-tartaric acid in DMF as a solvent gave preferentially the S-form of amlodipine tartrate directly from the reaction. The optimization of this approach by adjusting the water percentage in DMF ensured consistent purity of S-amlodipine (+99%) and satisfactory resolution efficiency.




Concise Synthesis of Two β-Adrenergic Blocking Agents in High Stereoselectivity Using the Readily Available Chiral Building Block (2S,2′S,2″S)-Tris-(2,3-epoxypropyl)-isocyanurate(Link)

Org. Process Res. Dev
August 24, 2011
A concise synthesis of (S)-propranolol and (S)-metoprolol in high stereoselectivity using the readily available chiral building block (2S,2′S,2″S)-tris-(2,3-epoxypropyl)-isocyanurate (S-TGT) as the key intermediate is described.
http://pubs.acs.org/doi/abs/10.1021/op2001518
API R & D Centre, Emcure Pharmaceuticals Ltd., ITBT Park, Phase-II, MIDC, Hinjewadi, Pune-411057, India
Org. Process Res. Dev.201115 (6), pp 1365–1370
DOI: 10.1021/op2001518

Abstract Image
A concise synthesis of (S)-propranolol and (S)-metoprolol in high stereoselectivity using the readily available chiral building block (2S,2′S,2″S)-tris-(2,3-epoxypropyl)-isocyanurate (S-TGT) as the key intermediate is described.



Simple Modification To Obtain High Quality Fludarabine(Link)

Org. Process Res. Dev
April 2, 2012
A simple and improved debenzylation process is described to obtain fludarabine in greater than 99.8% purity and 90–95% yield.
http://pubs.acs.org/doi/abs/10.1021/op3000509

API R & D Centre, Emcure Pharmaceuticals Ltd, I.TBT Park, Phase-II, M.IDC Hinjewadi, Pune-411057, India
Org. Process Res. Dev.201216 (5), pp 840–842
DOI: 10.1021/op3000509
Abstract Image
A simple and improved debenzylation process is described to obtain fludarabine in greater than 99.8% purity and 90–95% yield.




Identification, Synthesis, and Strategy For Minimization of Potential Impurities Observed In Raltegravir Potassium Drug Substance(Link)

Org. Process Res. Dev.,
July 13, 2012http://pubs.acs.org/doi/abs/10.1021/op300077m
API R & D Centre, Emcure Pharmaceuticals Ltd., ITBT Park, Phase-II, M.IDC Hinjewadi, Pune - 411057, India.
Org. Process Res. Dev.201216 (8), pp 1422–1429
DOI: 10.1021/op300077m
Abstract Image
Multiple sources of anticipated degradation and process impurities of raltegravir potassium drug substance observed during the laboratory optimization and later during its bulk synthesis are described in this article. The impurities were monitored by UPLC, and their structures are tentatively assigned on the basis of fragmentation patterns in LC–MS and NMR spectroscopy. Most of the impurities are synthesized, and their assigned constitutions were confirmed by co-injection in UPLC. In addition to the formation, synthesis, and characterization, strategy for minimizing these impurities to the level accepted by ICH is also described. We feel that our study will be helpful to the generic industry for obtaining chemically pure raltegravir potassium.


from the corresponding 3,5-dihydroxy pentanoic acid derivative; in the absence or presence of orthophosphoric acid or its alkali dihydrogen salts or alkali hydrogen salts of a dibasic acid, followed by optional neutralization of the reaction mixture with an organic base 
US 7777056 B2

FIELD OF INVENTION
The present invention relates, to an improved method for manufacture of 4-hydroxy-pyran-2-one derivative of formula (I) from the corresponding 3,5-dihydroxy pentanoic acid derivative of formula (II) in high purity.
Figure US07777056-20100817-C00004



Pune
















AMALNER

Map of amalner maharashtra


Amalner is located in Maharashtra









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