FTUG provides unique solution for product development in accordance QBD guidance and regional regulatory requirements. We deliver cost efficient technology.
FTUG provides complete solution for method development, validation, release testing, and stability testing under EMA and FDA compliant testing laboratory.
We provide contract manufacturing services at competitive prices adhering to strict quality standard, our facilities are in compliance with EMA and FDA GMP standard.
FTUG provides regulatory consulting for your product approval in EU and USA. We provide assistance for ANDA, / NDA applications, DMF /ASMF submission
First Time US Generics (FTUG) is an emerging pharmaceutical company with core expertise in development, manufacturing, testing, regulatory, patent litigations and distribution. FTUG provides unique solutions to pharmaceutical companies across the globe, unlike other contract research and manufacturing organizations FTUG takes complete responsibility of product development and commercialization. FTUG accepts challenges and commit to deliver the project on time.
Within a year of establishment FTUG developed and submitted 4 ANDAs under paragraph IV patent certification and all of those are accepted by FDA
How FTUG can assist you ?
to become FDA inspected manufacturer
to launch your company or product in the US
to file products involving PIV certification
to become compliant after adverse actions from US-FDA
We can provide complete turnkey solutions and cost effective delivery on an accelerated timeline which cannot be matched by others.Our access to global network will provide you the highest level of quality, safety, and service in generic pharmaceuticals at the best value.
We offer you an established platform to launch your company or product faster and economical way. We are flexible, transparent and accountable to your clients
FTUP has its own testing and manufacturing facilities with state of art infrastructure in compliance with ICH , FDA and EMA guidance. If you are looking for investment or product development in United States and European regions FTUG is the one stop destination.
Apart from product development and regulatory consulting we provide routine testing and stability testing services for the small and medium scale pharmaceutical companies.
FTUG has its presence in India with state of art testing facility to provide quality services at highly competitive price.
August 27, 2021
FTUG has started its own testing facility in India to provide cost efficient testing and development services.
August 27, 2021
FTUG has started its own testing facility in India to provide cost efficient testing and development services.
August 27, 2021
FTUG has submitted ANDA for Prasugrel Hydrochloride under paragraph IV patent certification.
August 27, 2021
FTUG is established in year 2013 , within two years successfully developed 4 products and submitted ANDAs under…