Quality, Expertise, Global Success.
Amber LifeSciences is a trusted provider of high-quality, affordable generic medicines and services, including CMO, CDMO, CRO, and Loan Licensing. Accredited by WHO-GMP, USFDA, EUGMP, and TGA, we ensure reliable supply, competitive pricing, and regulatory expertise for global healthcare markets.
25+ Product Range with Regulatory Support
Amber LifeSciences provides an extensive portfolio of over 25 product types and formulations, complemented by robust regulatory support. We ensure a seamless approval process for your healthcare products, empowering you to bring innovative solutions to market with confidence.
Tablets
Capsules
Lotion
Injection
Eye Drops
Inhaler
Human Albumin
Ointments
Syrup
Nasal Sprays
Infusion
Biological
Expert Regulatory Guidance for Registration
At Amber LifeSciences, our dedicated Drug Regulatory Affairs team collaborates closely with you, delivering comprehensive documentation and expert guidance for product registration. With our unwavering support, you can trust in a streamlined, hassle-free path to regulatory clearance, ensuring your success in the market.
50+ Exporting
Countries
7000+ Product
Lines
500+ Clients
Globally
500+ Ready
Dossiers
Why Choose Amber LifeSciences For CMO?
Amber LifeSciences delivers advanced CMO services, scaling drug production from development to commercialization with precision. Our expertise accelerates time-to-market, ensures compliance, and drives efficiency in a highly regulated industry.
CTD and ACTD Dossiers
Complete documentation for global regulatory submissions.
Essential Certifications
Free Sale Certificate (FSC) and Certificate of Pharmaceutical Product (COPP) for global distribution and approval.
Bioequivalence (BE) Studies
Supporting product approval with essential data and reports.
Product Samples & Analysis
Providing samples, Certificate of Analysis (COA), and product verification for registration.
Post-Approval Support
Ensuring continued regulatory adherence with ongoing support.
Regulatory & Consultation
Expert guidance and tailored documentation for country-specific requirements.
Connect with Amber for Your CMO Manufacturing Solutions and Innovations!
Your CMO Manufacturing Solution Awaits — Connect with us Now!”
Accelerate drug production with Amber CMO
Choose Amber LifeSciences CMO for Efficient, Reliable drug production and innovation.
24/7 Fast Support
Experience 24/7 fast support with our dedicated and reliable CMO services.
FREE Web-Consultation
Get FREE Consultations and Expert support from our dedicated CMO services.
What is a Contract Manufacturing Organization (CMO)?
A CMO is a company that provides outsourced manufacturing services to pharmaceutical and biotechnology firms, specializing in the production of drug substances and formulations while ensuring regulatory compliance.
What services do CMOs offer?
CMOs offer a range of services, including formulation development, drug product manufacturing, regulatory compliance, validation processes, and packaging, enabling clients to efficiently produce and launch their products.
How do CMOs ensure quality and compliance?
CMOs adhere to stringent regulatory standards, such as Current Good Manufacturing Practices (cGMP), and implement robust quality control measures, including regular audits and validation processes, to ensure consistent product quality.
What are the benefits of using a CMO?
Partnering with a CMO can reduce production costs, accelerate time-to-market, provide access to specialized expertise and technologies, and offer flexible capacity to meet fluctuating demand without significant investments in in-house facilities.
How do I choose the right CMO for my needs?
Consider factors such as the CMO’s expertise in your specific drug type, their capacity to meet production demands, their track record for quality and compliance, and their ability to communicate and collaborate effectively throughout the manufacturing process.
About Us
Discover the story and mission driving AmberLifeSciences forward.