Megafine Pharma (P) Ltd.


	The company’s R&D strengths are in creating intellectual property asset by developing non-infringing, novel, cost effective and environmentally friendly processes for API’s and finding easier solutions to complex chemistry challenges. We are specialized in constructing chiral molecules with strong expertise and experience in the resolution processes.

	Our R&D team consists of more than 40 qualified scientists with extensive expertise and experience in Process Research and Development activities for API’s and their critical intermediates.

	Our main philosophy is backward integration of API’s synthesis starting from basic raw material, thereby being self dependent for critical intermediates to control the cost and quality.

	Solid state studies, particularly polymorphism and particle size are proving to be bottle neck in marketing newer API’s. At Megafine, scientists are skilled in providing the solutions to the problems associated with them.

	We have two research centers, one at Nashik, Maharashtra, India and another at Vapi, Gujarat, India. R&D center at Vapi is mainly focused to provide critical intermediates with high purity and low cost through intensive research to our main R&D center at Nashik and as well as to API manufacturers around the globe.

	A well equipped R&D center is supported by kilo lab having reactors from 5 lit to 250 lit, SSR/GLR vessels to solve scale-up issues at production.

	We are very specific in creating online documentations for various phases of process development including the scale-up, safety, and engineering reports which help production to have the safe and robust process and to support regulatory filings.


Well equipped R&D centre with the state of the art facilities
Process development and continuous improvement to meet the cost
Innovative chemical research and process development for new APIs
Technology Transfer Team for smooth transfer of process from R&D to Manufacturing through Pilot Plant
Experts in evaluating Polymorphs
Polymorph synthesis and characterization
Robust Process Development guidelines and reports
Wide Reaction capabilities few of which includes;

	Alkylation	Halogenations
	Amidation	Hydrazine Chemistry
	Condensation	Hydrogenation
	Cyanations	Nitrations
	Cryogenic Reactions	Oxidations
	Etherification	Piperazines
	Esterifications	Reductions
	Formylation	Resolution Tech
	Friedel Crafts Reaction	Thiophene
	Grignard Reaction	Witting
	Swern’s oxidation	Gewald


		Skilled & experienced manpower with well equipped laboratories having HPLC (with PDA, UV, & RI detector), GC, GC-HS, UV, IR, Polarimeter, Potentiometer, KF titrator etc

		Analytical Method development and Method validations
		Impurity profiling and degradation studies


		Indian Patent Application no. 1073/MUM/2008 filed on 21st May 2008
			An Improved Process for the Production of Donepezil HCl Polymorph-1 and Intermediate thereof
		Indian Patent Application no. 516/MUM/2009 filed on 9th March 2009
			A new method for the preparation of Cinacalcet HCl and new intermediates thereof.
		Indian Patent Application no.519/MUM/2009 Filed on 9th March 2009.
			“A new method for the preparation of Solifenacin and new intermediate thereof.”
		PCT Application no. PCT/IN2009/000476 filed on 31st August 2009.
			“A New Method for the Method for the preparation of Solifenacin Succinate and New Intermediate thereof. “ Claiming priority from Indian Patent application 519/MUM/2009 filed on 9th March 2009

		PCT Application no. PCT/IN2009/000557 filed on 8th October 2009.
			“A new method for the preparation of Cinacalcet and new intermediates thereof” Claiming priority from Indian Patent application 516/MUM/2009 filed on 9th March 2009 In the name of Megafine Pharma (P) Ltd.

		Indian Patent Application No. 1859/MUM/2010 filed on 23rd June 2010
			“A novel process for manufacture of R (-) Mirtazapine and S (+) Mirtazapine”


		Donepezil HCl “. An Improved & Efficient Process for the Production of Donepezil Hydrochloride:
			Substitution of Sodium Hydroxide for n-Butyl Lithium via Phase Transfer Catalysis. Org. Process Res. Dev., 2008, 12 (4), pp 731–735”
		Quetiapine Hemifumarate “. An Improved and Single Pot Process for the Production of Quetiapine
			Hemifumarate Substantially Free from Potential Impurities. Org. Process Res. Dev., 2009, 13 (4), pp 792–797”
		Quetiapine Hemifumarate “.Original GC–FID Determination of Non-Chromophoric Impurities in Quetiapine:
			An Antipsychotic Drug. J. Chromatographia, (2010)
		Dipyrazolopyridines: Synthesis and Fluorescence Properties 5 of Donor-Acceptor-Substituted
			Novel Dipyrazolo[3,4-b:3′,4′-d]Pyridines (DPP); J. Fluorescence, (2010), Published online during Feb 2010 (Note: This work belong to KTHM college, I was just a co-author of the article because of my guidance to the team)

		Cinacalcet Hydrochloride: An Efficient Synthesis and Practical Resolution of 1-(Naphthalen-1-yl) ethanamine
			A Key Intermediate for Cinacalcet. Syn.Comm., (2010), Under production


		Respect for IP
		Patents landscaping
		Developing Non-infringing and Cost Competitive Schemes
		Filing Patents
		Providing NI opinions
		Research publications