Business Details
12 Years
experience
Trusted USFDA Registered Pharmaceutical Company in Fremont, CA
Founded in 2014, CitraGen Pharmaceuticals is a USFDA-registered pharmaceutical company driven by a mission to develop affordable, value-added drug products from concept to commercialization. Our team of three experienced pharmaceutical professionals brings over 60 years of combined expertise in pharmaceutical management, research, and commercial operations. We specialize in over-the-counter (OTC) products, prescription generics (ANDA), and new drug products (NDA), leveraging cutting-edge science and technology to address niche market opportunities. Our values of integrity, respect, and innovation guide every decision, ensuring quality remains central to our operations. With a focus on complex manufacturing processes and regulatory challenges, we deliver tailored solutions that differentiate us in the industry.Our research-driven approach identifies underserved therapeutic areas, enabling us to create products with specialized manufacturing requirements that establish competitive barriers. We maintain a quality-focused scientific team dedicated to advancing drug development through rigorous analytical methodologies and technical expertise. Our commitment to transparency and ethical practices extends to all stakeholders, including customers, partners, and employees. As a privately held company based in Fremont, California, we continue to invest in R&D to expand our pipeline and enhance operational excellence. Our long-term vision is to become a trusted leader in delivering high-quality pharmaceutical solutions that meet evolving market needs while maintaining affordability and innovation.
Services
OTC Drug Development
Prescription Generics (ANDA)
New Drug Products (NDA)
Pharmaceutical Research
Complex Manufacturing Solutions
Details
- Year established: 2014
Highlights and features
- We have over 60 years of combined pharmaceutical industry experience.
- Our USFDA-registered facility ensures regulatory compliance and quality assurance.
- We specialize in complex drug development with specialized manufacturing processes.
- Our team identifies niche market opportunities with less competition.
- We maintain a quality-driven scientific approach to drug commercialization.
Associations and certifications
- USFDA
Services
OTC Drug Development
We develop innovative over-the-counter drug products addressing underserved therapeutic areas. Our process identifies niche market opportunities with specialized manufacturing requirements. This approach enables us to deliver first-to-market solutions while maintaining strict quality standards through USFDA-compliant development protocols.
Prescription Generics (ANDA)
Our ANDA portfolio focuses on complex generic drug formulations requiring advanced analytical methodologies. We navigate regulatory challenges to deliver cost-effective alternatives to branded medications. Our expertise includes specialized packaging and processing solutions for technically demanding generic products.
New Drug Products (NDA)
We develop novel drug formulations through rigorous research and clinical testing. Our NDA process addresses intellectual property barriers and complex regulatory pathways. This service targets therapeutic areas with unmet medical needs, utilizing proprietary manufacturing technologies to create differentiated pharmaceutical solutions.
Pharmaceutical Research
Our research division employs cutting-edge technologies to analyze market opportunities and technical challenges. We focus on identifying high-value drug development targets with competitive barriers. This includes specialized analytical methodologies for complex formulations and regulatory compliance strategies.
Complex Manufacturing Solutions
We provide manufacturing capabilities for drugs with technically challenging production requirements. Our facility handles complex packaging, processing, and quality control protocols. This service addresses products with regulatory hurdles or specialized analytical testing needs, ensuring consistent compliance with industry standards.
People
Not explicitly named
Pharmaceutical Professionals
Three founding pharmaceutical professionals with 60+ years combined experience in research, management, and commercial operations lead CitraGen's drug development initiatives.
Questions
What types of pharmaceutical products does CitraGen develop?
We develop over-the-counter medications, prescription generics (ANDA), and new drug products (NDA) with specialized manufacturing requirements.
Is CitraGen FDA-registered?
Yes, we are a USFDA-registered pharmaceutical company with compliance protocols for all our drug development and manufacturing operations.
What makes CitraGen's approach unique?
We focus on niche therapeutic areas with complex manufacturing challenges, creating competitive barriers through specialized analytical methodologies and proprietary technologies.
Where is CitraGen Pharmaceuticals located?
Our headquarters and manufacturing facility are located at 3789 Spinnaker Court, Fremont, California 94538.
How does CitraGen ensure product quality?
We maintain a quality-driven scientific approach with rigorous analytical testing, regulatory compliance, and continuous investment in research and development.
What experience does the leadership team have?
Our founding team includes three pharmaceutical professionals with 60+ years combined experience in research, academic, retail, and commercial operations.
