Apogen remedies profile

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Welcome to

Client’s Name

About Apogen

Apogen Remedies Pvt. Ltd.

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Apogen…Driven by Quality and Powered by Innovation!

Apogen is a Quality driven Pharmaceutical company Focusing on Research & Development, Manufacturing & Marketing of ready to fill pellets in India and Global markets.

Our BusinessApogen offers Immediate and Modified Release Pellets for wide range of

generic drugs in various Therapeutic segments.

Our Mission

Our VisionTo become one of the leading Indian Pharmaceutical companies in the

Global market in developing novel drug delivery systems in acute & chronic therapeutic segments to help people lead healthier and Quality life.

Quality Products for Quality Life through Innovation

To provide better healthcare to the humanity with affordable drugs of uncompromised Quality and to pursue excellence in healthcare through

innovation & empowered personnel.

Apogen Objectives



Short Term

To identify conventional dosage forms for formulation in to NDDS at a later stage.

To Establish our position in Indian Market and to Strive for leadership in at least one therapeutic segment.

To enter International markets with special focus on Emerging Markets.

Medium Term

To develop & manufacture the targeted drugs in NDDS form and commercialize them after regulatory approvals.

To Consolidate presence in the Indian market our position as the leaders in at least one therapeutic segment.

To Establish & Spread our activities in the EMs and to evolve strategies for the markets of US & Europe.

Long Term

To become a vertically Integrated Pharma company APIs, Ready to fill pellets, DC granules & Formulations.

To consolidate our activities in the EMs and consolidate leadership position in 1 or 2 therapeutic segments.

To gear up and enter USA, Europe & other regulated markets.

Why Apogen



Apogen is a Breed Apart! Apogen is not a mere product supplier!!

Apogen is indeed your technical partner!!!

Our Promoters & Top Executives have rich experience and expertise with leading MNCs in the areas of:

Product Development, Analytical Development,

Technology Transfer

Product Development, Analytical Development,

Technology Transfer

Sales, Marketing & Distrubution of

pharmaceutical products

Sales, Marketing & Distrubution of

pharmaceutical products

Projects, Stability Management, Manufacturing

Projects, Stability Management, Manufacturing

Quality Control, Quality Assurance, Regulatory Affairs

Quality Control, Quality Assurance, Regulatory Affairs

Core Strengths

Core Strengths

Apogen Offers!



Built-in-Quality products

Cost Competitive

advantage

Regulatory Documentation DMF/Dossiers/ Tech.data pack

Technical Partnering

Pharma Consultancy

Services

Customer Service at

its best

WIN-WIN Business

Model

Mutually beneficial Long Term association

ApogenOffers

Manufacturing



Manufacturing facility is GMP, ISO 9000-2008 certified, Inspected by International regulatory authorities and located in an eco friendly environment at Hyderabad, INDIA.

We develop, manufacture & deliver the most STABLE products to our customers by:

Adhering to Good Manufacturing and Documentation Practices

Adopting Well Qualified & Calibrated Equipments, Instruments & Supporting Systems (HVAC, Water etc.)

Subjecting our Products, Analytical Methods, Cleaning Procedures & Computer systems to Periodic Validations and Practicing Well Maintained Change Control Procedure

Qualified, Experienced & Trained Personnel

Maintaining Quality Standards Consistently is thus the commitment of our company to meet the Global Regulatory Requirements

Our Products


Omeprazole Lansoprazole Esomeprazole Pantoprazole Rabeprazole Domperidone Mebeverine Itopride Ome + Dome Rabe + Dome Panto + Dome Panto + Itopride Rabe+ Itopride

CNS & CVSDrugs

Gastro Intestinal Drugs

Gastro Intestinal Drugs

CNS & CVSDrugs

NifedipinePropranololFenofibrateFluoxetineVenlafaxineTheophyllineCaffeine

Analgesic NSAIDs & Others

Analgesic NSAIDs & Others

DiclofenacKetoprofenTramadolAspirinDoxycyclineTamsulosin

Cough, Cold & NutraceuticalsCough, Cold & Nutraceuticals

Ambroxol PhenylephrineCetrizineCPMIronZincVitamins in various combinations..

Anti ObesityDrugs

Anti ObesityDrugs

Orlistat


Sales & Marketing – National


Identified the gaps in therapeutic segments & expanded the product basket with new and innovative products

Identified and linked up additional manufacturing capacity to cater to the enhanced demand

Pooled up additional finance to meet the expanded business needs

India - a Key market in BRICS-MT pharmerging markets

Built-in-Quality

Customer service at its best

WIN-WIN business model &

Mutually beneficial LONG TERM association


Apogen's Commandments of success:


Sales & Marketing - Overseas Offices


Phase – I

Phase - II

Dubai

Sao Paulo

Vietnam

Chicago

Singapore

Sydney

Lagos

London Kiev Toronto


Collaborative Business


Sales & Marketing:

Apogen Looks forward for Agents & business associates in India and abroad for Immediate and Modified Release pellets We believe in WIN-WIN business model & mutually beneficial association

Research & Development:

Open for collaborative research work for the new and complex drugs

Joint Venture Opportunities:

Collaborations for exchanging technical Know-how of various products including the latest drugs for pellets

Collaborative business:

Opportunities in Formulation Research & Development, Co-development, Technology Transfer, Regulatory Registrations, Clinical Research, Contract Manufacturing, Distribution, Marketing, Joint Ventures and many other similar activities


Consultancy Services


Our Chief Consultants:

Principal Consultant : Mr. Adnan Sabir, M.S. R.Ph., (USA) GMP & Validation Consultant : Dr. Bhanu Prasad K, MS (Pharma), Ph. D (Canada) Regulatory Consultant : Mr. D Hanumantha Rao, B.Pharm, PG Dip In Hosp. Admin FR & D Consultant : Dr. RAS Naidu, M.Pharm, Ph. D, PG Dip in Patent Law

Areas of Consultancy


Formulations Development: emphasis on 'high barrier', 'high potency' compounds in solids, liquids, topical, MR, Parenterals & novel dosage forms

Technology Transfer: Formulation & Process Optimization, Trouble Shooting, Technology Transfer from Development to commercial, outsourcing phases etc.

Regulatory Affairs: Preparation and/or Review of CMC sections for NDA and ANDA. Interaction with Regulatory Agency to resolve issues related to approval Writing and/or Review of Reports

Bioequivalence Services: We can help client companies identify suitable CROs in India, Canada and the USA for carrying out bio studies.

Quality: Providing excellent guidance in understanding of 21st Century Quality Initiatives of FDA for QbR, QbD, & PAT (ICH GL 8,9, 10 and 11)

Contact us


Apogen Remedies Pvt. Ltd.12-7-133/G/2, 1st Floor, Sri Siva Sai Enclave, Anjaneya Nagar, Moosapet, Hyderabad - 500 018

Tel : +91-40-23868067 Fax : +91-40-40035597

Mobiles : +91-986-639-9882+91-939-177-3305 +91-965-202-3499

Email : [email protected]

Visit us at : www.apogen.in


mailto:[email protected]

http://www.apogen.in/

Disclaimer



This presentation as well as our website contains statements that constitute “forward looking statements” including and without limitation, statements relating to the implementation of strategic initiatives, and other statements relating to our future business developments and economic performance.

While these forward looking statements represent our judgment and future expectations concerning the development of our business, a number of risks, uncertainties and other important factors could cause actual developments and results to differ materially from our expectations.

These factors include, but are not limited to, general market, macro-economic, governmental and regulatory trends, movements in currency exchange and interest rates, competitive pressures, technological developments, changes in the financial conditions of third parties dealing with us, legislative developments, and other key factors that we have indicated could adversely affect our business and financial performance.

Apogen undertakes no obligation to publicly revise any forward looking statements to reflect future events or circumstances.

Apogen remedies profile

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