
Is There a Big Audience for Minoxidil?
The industry for hair loss treatments keeps growing yearly and is close to 3.9 billion dollars. As a daily-used product, Minoxidil can create brand loyalty and additional traffic for your product.
What solution of Minoxidil do you manufacture?
Pure Source manufactures 2% Minoxidil Solution for Women and 5% Minoxidil Solution for Men. As a licensed US Minoxidil manufacturer, we specialize in providing high-quality formulations tailored to meet the diverse needs of brands in the Hair Care industry.
When it comes to proven products that treat baldness or thinning of hair, Pure Source has you covered! Pure Source is listed in the Orange Book as the ANDA holder for two types of Minoxidil products. Pure Source can manufacture 2% and 5% Minoxidil Solutions for your brand. So, you can give your customers approved, hair regrowth treatments that fit their hair care needs. We are the go-to US Hair Loss Manufacturer, offering scalable production to accommodate brands of all sizes, from startups to established enterprises.
Who Can Benefit From Minoxidil?
Minoxidil helps both male and female baldness or thinning hair on the top of scalp. As a specialized Minoxidil for women manufacturer, we ensure that our formulations cater specifically to the unique needs of female consumers, promoting safe and effective hair regrowth solutions.
Does Minoxidil need FDA approval to be sold?
Yes, FDA approval is required. Our regulatory department can help you with listing your over-the-counter Minoxidil products and also help to make sure your packaging artwork and information is compliant and good to go! As a 2 percent and 5 percent Minoxidil manufacturer, we adhere to rigorous quality and compliance standards, ensuring our products meet all FDA regulations for over-the-counter hair loss treatments.
Made in USA
Call us today to learn how we can help you with your full turnkey Minoxidil needs! 305-477-8111


An emerging hair care brand set out to enter the professional regrowth category with a product designed for daily application and clinically proven results. Recognizing that visible performance is the key to building consumer trust, the brand sought to launch a high-performance mens and womans Minoxidil treatment as the foundation for their entire line. They required a licensed, turnkey manufacturing partner capable of navigating the complex regulatory landscape of OTC hair regrowth treatments while ensuring the formula delivered consistent clinical efficacy.
Pure Source partnered with the brand to provide a complete turnkey manufacturing solution. Our regulatory team worked closely with the client, providing expert guidance to ensure a fully compliant product. Through an iterative design and regulatory process, our team refined multiple rounds of artwork to ensure the final labels met all OTC requirements while maintaining a premium aesthetic. These formulations underwent extensive stability testing and clinical review, resulting in a final, approved Minoxidil treatment that delivers superior regrowth performance without compromising hair texture. Because of these proven clinical results, the brand built immediate consumer trust, allowing them to successfully scale and launch a full line of complementary hair care products.
Emerging Hair Care Brand (NDA Protected)
Minoxidil 2% and Minoxidil 5% Hair Regrowth Treatment
10,000 units
250,000+ units
Up to 100,000 units per day
FDA-registered, cGMP-compliant U.S. manufacturing
Pure Source offers full-service, turnkey contract manufacturing for topical minoxidil solutions (2% and 5%). Our comprehensive services include formulation, testing, and packaging, all conducted in an FDA-registered, cGMP-compliant facility
Yes. All minoxidil production occurs in our FDA-registered, cGMP-compliant U.S. Miami facility.
We produce FDA-approved concentrations such as 2% and 5% minoxidil for hair regrowth.
Yes. All products comply with FDA OTC monograph guidelines and drug labeling requirements.
MOQ is 5,000 units per SKU.
We offer minoxidil formulas in different forms.
Production timelines run 10–12 weeks depending on formula and packaging.
Yes. We provide full OTC label design, ingredient verification, and packaging sourcing.
Every batch undergoes potency, stability, and microbial testing to ensure compliance and safety.
Pure Source is a trusted U.S. OTC manufacturer known for regulatory accuracy, quality assurance, and reliable minoxidil production.
We would love to hear about your project and discuss how we can help. To schedule a meeting with our team, simply fill out the form in this section.
+1 (305) 477-8111
info@thepuresource.com