Growing globally in oncology space. Content  About us Facility Certifications Presence Products  Future Plan and New Facility.

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Presentation transcript:

Growing globally in oncology space

Content  About us Facility Certifications Presence Products  Future Plan and New Facility

Getwell Overview Getwell, is a pharmaceutical company primarily operating to innovate, develop, and manufacture world class oncology drugs. We make every effort to transform and simplify care for people with life-threatening diseases mainly cancer, by focusing on our core capabilities.

Getwell’s Quality Policy “At Getwell, Quality is a relentless commitment to continual improvements in product, processes and systems to provide assurance to meet our customer’s requirement worldwide.”

About Us  Getwell was established in year 1985 by our Founder Sh. Rajiv Tandon  Getwell began as a manufacturer for ophthalmology products & Multi-Vitamin Injections  Getwell constructed its new and current facility in 1995 – Only GMP certified factory at that time in this region.  Dedicated ourselves into oncology space by the year  Present and registered in more than 25 countries worldwide  As of now, we are in Top 20 of India Generic Oncology Companies with an annual turnover of US$ 6mn, and growing.

Core Capabilities  Product Mix : 40 molecules strong product mix targeted to various forms of cancer  Infrastructure : Compliant, Compact, Cost-effective and Reliable. Four most important pillars of an oncology facility  Garnering strength through partnership : Suppliers of API, Hospitals, Doctors, Pharmacists, Supply Chain; each adding previous value

About the Manufacturing facility  Commissioned in the year 1995  Built up Area: 6000 sq. feet  Principal Certifications: GMP, WHO-GMP, GLP and ISO  Manufacturing capabilities – Specializing in Oncology  Lyophilization  Liquid Vial filling  Powder Vial Filling  Liposomal formulation processing

Certifications and Presence  South and South-East Asia  India  Nepal: Audited and Approved by DDA  Sri Lanka: Audited and Approved by NMRA (Ex-CD&DA)  Vietnam: Approved and Registered by DAV  Philippines: Approved and Registered by FDA  Mongolia: Approved and Registered by FDA  Cambodia: Approved and Registered by MOH  Central Asia  Kazakhstan  Uzbekistan  Kyrgyzstan

Certifications and Presence  Africa (Continued)  Mauritius: Approved and Registered with MOH  Madagascar: Approved and Registered with FDA  Seychelles: Approved and Registered with MOH  Ghana: Approved and Registered with FDA  Kenya: Audited and Approved by PPB  Zambia: Approved and Registered by FDA  Nigeria: Approved and Registered NAFDAC  Dom. Rep. of Congo  Burkina Faso

Certification and Presence  Latin America and the Caribbean's  Guatemala: Approved and Registered by FDA  Dominican Republic: Approved and Registered by FDA  Cuba: Approved and Registered by FDA  Trinidad & Tobago: Approved and Registered by FDA  Jamaica: Approved and Registered by FDA  Under registration  Belarus  Turkmenistan  Costa Rica  Tanzania

Products  Product Mix – Comprising of more than 40 molecules targeted to both solid tumors and blood-related malignancies.  Stability – Studies pertaining to stability conducted at different Temp. Zones to ensure product stability in both real time and accelerated.  Pharmaceutical Equivalency – Each Product prior to launch undergoes pharmaceutical equivalency study with respective innovator brand and launched post-approval only.

Getwell – Future Plans  New Manufacturing Facility  Location : Industrial Town, Bawal, Haryana  Land Area : 8000 sq. meters  Built-up Area : 40,000 sq. feet  Products – Sterile Oncology Formulations including MABs  Expected Approvals : US-FDA, EU-GMP, PIC/s, ANVISA, MCC, TGA, WHO.  Target Completion Date : September 2018

New Facility Plan  Manufacturing Facility  Principal Activity: Manufacturing & packaging of anti-cancer Injectable formulations for supply to the US, Europe and Rest of the world markets.  Production Capabilities  Liquid Injectables  Lyophilized Injectables  Production Capacity : 6 Mn units/year

Technologies and Capacities  Liquid inj: 4 Mn / annum  Lyophilized inj: 2 Mn / annum  Capability: 0.5 ml to 99 ml.  Technologies: Aseptic Manufacturing Closed Restricted Access Barrier system Lyophilization Liposome manufacturing for Drug-Delivery based products CIP and SIP Building Management System CCTV monitoring - All critical operations SCADA system – Water system CIP / SIP System

New facility – Prospective Look

New Facility – Prospective Look Class B Corridor cRABS-Filling Line

New Facility – Prospective Look Purified Water Generation WFI and PS Generation

Thanks A lot !