Business Details
13 Years
experience
Trusted Pharmaceutical Development and Manufacturing Services
First Time US Geneics (FTUG) is an emerging pharmaceutical company established in 2013, specializing in comprehensive solutions for generic drug development, manufacturing, and regulatory compliance. Our expertise spans product development, analytical testing, contract manufacturing, and regulatory consulting, with a focus on delivering FDA and EMA-compliant services. We operate state-of-the-art facilities in Broomall, PA, and India, offering cost-efficient testing and development services. Our team of experienced professionals takes full responsibility for product development from concept to market launch, with a proven track record of submitting ANDAs under paragraph IV patent certifications.We prioritize quality by design, adhering to ICH guidelines and maintaining strict compliance with global regulatory standards. Our services cater to small and medium-scale pharmaceutical companies seeking accelerated timelines and cost-effective solutions. Through a global network, we ensure high-quality, safe, and compliant generic pharmaceutical products. Our commitment to transparency, accountability, and client satisfaction drives our mission to support partners in achieving commercial success.
Services
Product Development
Analytical Services
Contract Manufacturing
Regulatory Consulting
Patent Litigation
Distribution
Method Development
Stability Testing
ANDA Submission
Pharmaceutical Testing
Details
- Year established: 2013
Highlights and features
- We take complete responsibility for product development and commercialization.
- Our facilities comply with FDA and EMA standards.
- We offer cost-efficient services with a global network.
- Our team has extensive experience in ANDA submissions and regulatory compliance.
- We provide state-of-the-art infrastructure for testing and manufacturing.
Services
Product Development
FTUG offers end-to-end pharmaceutical product development services, from formulation design to regulatory-compliant commercialization. Our approach integrates Quality by Design (QbD) principles and ICH guidelines to ensure robust, scalable solutions. With expertise in solid oral dosage forms, sustained-release preparations, and topical formulations, we deliver methodical development plans that align with reference product criteria, ensuring bioequivalence and regulatory success.
Analytical Services
Our FDA-compliant analytical laboratory provides method development, validation, and stability testing for pharmaceuticals. Equipped with advanced instrumentation like HPLC, GC, and Karl Fischer titrators, we support impurity profiling, drug substance evaluation, and routine testing. Services include preformulation studies, cleaning validation, and stability storage under ICH guidelines, ensuring data integrity and compliance with 21 CFR Part 11 standards.
Regulatory Consulting
FTUG specializes in US and EU regulatory strategies, including ANDA/NDA submissions, eCTD conversions, and Paragraph IV certifications. Our experts conduct gap analyses, prepare deficiency responses, and manage lifecycle updates like annual reports. With deep knowledge of FDA and EMA requirements, we streamline approvals for complex generic drug applications.
Contract Manufacturing
We provide GMP-compliant contract manufacturing for diverse formulations, including tablets, capsules, and liquid dosage forms. Our Philadelphia facility features DEA licensing for controlled substances (CII-CV) and partnerships in India for cost-effective production. Services include process validation, equipment maintenance, and batch customization to meet client-specific quality and scalability needs.
Patent Litigation Support
FTUG offers specialized support for Hatch-Waxman litigation, including Paragraph IV certifications, patent opinions, and non-infringement analyses. Collaborating with US-based legal experts, we help clients navigate patent challenges, draft FDA submissions, and develop cost-effective strategies for market entry in generic pharmaceuticals.
Questions
What services does First Time US Generics offer?
We provide product development, analytical testing, contract manufacturing, regulatory consulting, patent litigation support, and distribution services for generic pharmaceuticals.
How does FTUG assist with FDA approval?
We offer regulatory consulting for ANDA submissions, eCTD conversions, DMF/ASMF filings, and deficiency response strategies to expedite FDA approvals.
What makes FTUG unique compared to other CROs?
We take full responsibility for product development and commercialization, combining FDA/EMA-compliant facilities with cost-efficient global operations.
Where are FTUG's facilities located?
Our primary facilities are in Broomall, PA, with additional testing infrastructure in India to support global clients.
Can FTUG handle complex patent certifications?
Yes, we specialize in Paragraph IV ANDA submissions and provide legal support for Hatch-Waxman litigation matters.
Reviews (1)
Hrushikesh Patil
Sep 21, 2015
Report
Great expertise of Dr, Manesh Dixt in patent analysis, pharmaceutical development and regulatory compliance.
