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Published byFrank Stanley Modified over 8 years ago
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Growing globally in oncology space
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Content About us Facility Certifications Presence Products Future Plan and New Facility
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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.
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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.”
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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 2000. 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.
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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
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About the Manufacturing facility Commissioned in the year 1995 Built up Area: 6000 sq. feet Principal Certifications: GMP, WHO-GMP, GLP and ISO 9001-2008 Manufacturing capabilities – Specializing in Oncology Lyophilization Liquid Vial filling Powder Vial Filling Liposomal formulation processing
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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
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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
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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
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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.
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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
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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
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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
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New facility – Prospective Look
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New Facility – Prospective Look Class B Corridor cRABS-Filling Line
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New Facility – Prospective Look Purified Water Generation WFI and PS Generation
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Thanks A lot !
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