Alvogen Inc, the US-based generic pharmaceuticals company, is planning to set up clinical services and an API sourcing office in Bangalore, India.
Alvogen, which has made an investment of US$ 5 million to commence its operations in India, will name the company Norwich Clinical Services.
Alvogen will open a dedicated centre for pharmacovigilance which is viewed as the next area of growth in the clinical research segment.
The CRO will be managed by Alvogen´s subsidiary Norwich Pharmaceuticals. The company will offer a complete range of clinical research capabilities, including phase I-IV trials, bio-analytical studies and pharmacovigilance monitoring.
The CRO will employ around 100 people, within its first year of operation. The Groups sourcing office operates under the Alvogen name.
The facility will span 30,000 sq ft and will be commissioned in June this year. The bio analytical lab will have 12 LCMS installed. Norwich Clinical Services has commenced hiring post graduates and doctorates.
The key reason for Alvogen to enter India is the vast opportunities in the area of clinical research. The hospital infrastructure, medical- scientific prowess of English speaking professionals, large naïve patient pool and cost advantage are other advantages, stated Sudhir Pai, director, Norwich Clinical Services.
The CRO will specialize in the management of clinical trials and offer a complete range of clinical research services to Alvogen and third parties, reports said.
In May, last year, Australian clinical research company Novotech entered into a strategic partnership pact with ETI Klinical Pvt Ltd of India.
The Novotech-ETI Klinical joint venture targets to serve the growing demand for global clinical research in the region. The companies will operate across India and offer full clinical and data management services.
Karle Group CEO Mr Mahendra Karle said that with the joint venture clients could access the company’s extensive reach across India which included Memorandum of Understanding with 92 pre-qualified sites with proven recruitment capability and compliance, providing access to over 5 million patients and 13,000 beds.
The therapeutic areas in which the Novotech-ETI Klinical joint venture operates include oncology, gastroenterology, urology, nephrology, ophthalmology, cardiology, diabetology, dermatology, orthopedics, postoperative pain, neurology, otorhinolaryngology, infectious diseases, respiratory diseases, endocrinology, psychiatry, geriatrics, hematology, metabolic disorders devices and vaccines.
In April 2009, the Indian CRO GVK Biosciences (GVK Bio) and Chinese Excel PharmaStudies (Excel) joined hands to offer clinical trial sevices in Asian region – a first-ever alliance between a Chinese and Indian CRO.
Under the terms of the arrangement, GVK BIO and Excel will help sponsors conduct and manage Phase II-IV clinical trials, statistical analysis and medical writing. Any India trial for Excel will be carried out by the GVK BIO clinical research team and will be managed by a core project management team of Excel.
Norwich Clinical Services is a contract provider for bioanalytical, pharmacovigilance and clinical research programs.
Norwich Clinical Services offers services in various dosage forms including parenterals, suspensions, topical preparations and delayed release formulations.
Norwich Pharmaceuticals is a full-service contract development and manufacturing provider for Rx and OTC pharmaceuticals.
Alvogen is a privately-owned pharmaceuticals company, focused on complex generic pharmaceuticals products.