Active Pharmaceutical Ingrediants - Regulated Market

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Regulated Market

Executive Summary of the company:

Morepen a high end Indian pharmaceutical player, is engaged in manufacturing high tech bulk drugs for international markets since 1984.

The company has prestigious USFDA approval & WHO GMP approval at its API plants

Established credentials as API &  intermediates supplier to large MNC players in regulated market & non regulated market 

One of the largest supplier of flagship of API, Loratadine, globally.

Developed new APIs supported by technical packages, followed by DMF & COS filing for several new blockbuster drugs like Atorvastatin&Montelukastalongwith commercial production.

Has a manufacturing facility for finished formulations having adequate capacities for tablets, capsules, liquids &poweders

Strong regulatory skills &well equipped R&D centre manned by over 40 trained scientists.

More than 100 satisfied customers world wide

Going for EU GMP & PMDA ( Japan) approvals

The company has remarkably established itself in the domestic market. For therapeutic segments for example, anti- histamines (Loratadine), anti- asthematic( Montelukast&Atorvastatin).

Having strong presence in the markets like USA, Europe, Canada & Japan.

Business objective- Continuous growth with Quality improvements, to satisfy customers at reasonable price, strong existence in EHS in the welfare of human & society


Possible structure for potential tie ups/ partnerships:

Morepen to be a preferred contract research/ manufacturing source for finished dosages

Morepen to align Research and Development activities to complement the generics strategies of the partners

Backward integration into APIs at Morepen's USFDA approved bulk drug plant possible

Morepen to provide ANDAs and add substantial value to the partners' efforts in the global    generics segments in the regulated markets.

Possible framework of relationship:

Work on development of products on a project basis

Conduct patent study/evaluation help formulate suitable patent strategy

Develop non-infringing processes

Provide full backend regulatory support including coordination with third parties for bioequivalence studies to develop ANDAs.

Options:

Partners can opt to file the ANDA based on the documentation by Morepen

Morepen can develop finished dosage forms and file for ANDA

Co-development route can also be considered

Develop APIs for the partners if desired and file DMFs

Net-net, Morepen will provide cost efficiency and speed to market advantage to the partners

Morepen - The Strategic Partner What we can offer to our partners Activities we could cover for our partners

Complete backend Chemistry Shop

R&D Co-development

Patent study and evaluation

Development of non infringing processes

Developing a launch strategy based on patent evaluation

Complete backup with international accredited facilities.

Filing of the DMF / development of finished dosage for the different markets

Filing of the pharma dossier / ANDA

Contract manufacturing at globally competitive prices

The key advantages proposed to our partnersp

Speed to market

Cost effectiveness - Indian backend with significant economies of scale

Strong and hi-tech API backup based on a completely integrated model reduces reliance on    third parties