Consultancy includes formulation, analytical, regulatory and compliance, contract manufacturing,
patent and can be a one stop solution for all industrial needs. Kindly fill the form below for your consultancy requirements:
First Time US Pharmaceuticals (India) Pvt. Ltd. (FTUP) is a USFDA registered and audited facility and a subsidiary of First Time US Generics LLC., established in 2013 under the leadership of Dr. Manesh Dixit, a professional and an entrepreneur.
To be a global leader in pharmaceutical industry by providing innovative products of assured quality at an affordable price.
To utilise available talents and technologies for the development of niche products that stands differently from the current treatment regimen. To serve the customer with needed formulation and analytical support.
First Time US Pharmaceuticals (India) Pvt. Ltd. is a one stop solution for all pharma needs that may include analytical services to the industry, formulation development of various dosage forms covering BCS class I to class IV drugs using in-house and novel platform technologies. FTUP has already developed products in the field of transdermal and topical, metered and non-metered spray technologies, soft chew tablets and semi solids for veterinary and human use. All these products are unique and have its own technological advantages and has potential for patent ability. Few patents are already at place. The company has special knowledge for solubility/bio-availability improvement of insoluble drugs, controlled and targeted release for improved compliance and developing bio-equivalent products as part of generic product development requirement. FTUP has been successful in stabilizing difficult to stabilize products and is ready to take up projects with potent and narrow therapeutic index drugs and difficult to achieve bio-equivalence products. FTUP can undertake technology transfer of already developed products and is well versed with current approaches and regulatory needs such as QbD, PAT and process qualification needs. FTUP regulatory team is well versed with submission requirements and other requirements such as CBE 30, PAS and other regulatory documentation needs. FTUP has successfully co-developed 9 ANDAs with our US counterpart. Our site is USFDA registered and audited facility approved.
Developing and providing pharmaceutical products and services of assured quality with outstanding level of commitment to integrity, reliability, delivery and continuous improvement at competitive price in compliance with the relevant laws and regulations.
Founder of First Time US Generics, Philadelphia, USA. & First Time US Pharmaceuticals (I) Pvt. Ltd., Navi Mumbai, India.
Dr. Manesh Dixit received his Ph.D. in Pharmaceutics from The Ohio State University in March, 1999. He joined The Ohio State University in September, 1994 after graduating with a pharmacy degree from the University of Mumbai in India.
Currently, Dr. Dixit is the president, Chairman and CEO of First Time US Generics LLC., which he founded. the company manufactures prescription branded and generic products including transdermal patches and oral solid dosage products for USA and foreign markets out of its FDA and DEA audited facilities in Miami, Philadelphia, Kansas city and Mumbai. In 2017, Dr. Dixit successfully acquired a large-scale commercial operation in Miami, Florida, an 180,000 sq. ft manufacturing facility, along with Nitr-Dur® (Nitroglycerin) Transdermal Infusion System from Merck Sharp & Dohme corp.
Prior to starting his business, he was a senior executive with multidisciplinary expertise in the pharmaceutical industry. His expertise included all aspects of pharmaceutical product development, FDA filing, the product launch, DEA matters and day to day plant operation. He is well-versed in the intricacies of regulatory strategies as well as in the resolution of patent and exclusivity issues and controlled substance compliance. He also passed the patent bar examination and is registered to practice before the USPTO.
Having about 27 Years of experience in the field of Formulation development involving novel delivery systems, technology transfer and ANDA submission. Has thorough knowledge in quality and compliance in Various MNCs such as Lupin, Astra, Ajanta Pharma, Cadila Pharma, Sidmak (Sun Pharma) and Mylan.