Browse Quasi-Drug cosmetics OEM manufacturers in Japan. Find contract manufacturing partners. Filter by small lot options and sample availability. Free consultations available.
Spray and deodorant specialized OEM in Sennan, Osaka. Expertise in medicated antiperspirant sprays and body care sprays with extensive PB manufacturing experience for major companies.
Cosmetics OEM specialized in mail-order and D2C, established 1999, Yoshikawa, Saitama. Expert in skincare and quasi-drug contract manufacturing with 900+ brand launch cases from 100 units at ¥300,000.
Founded in 2022 in Osaka. Cosmetics and health food OEM/ODM manufacturer supporting ultra-small lots from 100 units. Handles quasi-drugs and functional foods. Provides total production support including pharmaceutical law compliance, package design, and web creation.
A cosmetics and quasi-drug OEM manufacturer established in 1993 as a wholly owned subsidiary of Noevir. The company maintains over 10 sunscreen formulations with verified SPF/PA values. Bonanza also offers a wide range of quasi-drug products including acne care, whitening, and deodorant products. The strength lies in the Noevir Group's R&D capabilities and quality management system.
A cosmetics and quasi-drug OEM manufacturer established in 2013. With over 500 OEM contract achievements, the company accommodates small lots starting from 100 units. It holds numerous sunscreen formulations with verified SPF/PA values and can rapidly commercialize both non-chemical and chemical medicated sunscreens.
Not sure which manufacturer is best for you?
OEM JAPAN's team provides free consultation support. Tell us what you're looking for and we'll help.
A cosmetics OEM manufacturer established in 1980, based in Kyoto. With 45 years of continuous cosmetics creation and business relationships with over 7,000 companies. Started with professional-use cosmetics manufacturing for beauty salons and aesthetic salons, featuring proposals that leverage the Kyoto brand, such as the "Kyo no Uruou All-in-One Gel."
A Tokyo Stock Exchange-listed company (securities code: 2207) established in 1945. Changed its name from Meito Sangyo in 2025. In addition to the food business, operates manufacturing and sales of pharmaceuticals, quasi-drugs, and cosmetics through its Chemical Products Division. Strengths in raw material development of polysaccharides and enzymes through proprietary fermentation technology. Capital: 1,335.19 million yen.
Not sure which manufacturer is best for you?
OEM JAPAN's team provides free consultation support. Tell us what you're looking for and we'll help.
A cosmetics ODM company founded in 1960 and part of the Rohto Pharmaceutical Group. Ands Corporation manufactures skin care, hair care, and body care products, with 95% of its contract work handled as integrated projects from formulation development. The company operates two factories — in Tondabayashi and Nara — and complies with ISO 22716 guidelines. With 360 employees, the company has particular expertise in formulations for sensitive skin.
Japan's largest cosmetics OEM/ODM company, founded in 1912. Renamed from Nippon Kolmar in 2024. Approximately 200 researchers independently develop 90% of formulations, with a production system spanning 7 locations and 8 factories nationwide to handle all types of cosmetics. The company has 2,336 employees. Through its acquisition of Tokiwa, TOA has formed a group with a scale of 100 billion yen.
A member of the Daizo Group, providing OEM/ODM manufacturing of cosmetics, daily necessities, and aerosol products. Covers a wide range from bath products, hair care, and skin care cosmetics to industrial products. Licensed for quasi-drug manufacturing.
An OEM manufacturer engaged in the planning, development, and manufacturing of skin care cosmetics and quasi-drugs. Cosme Pro possesses proprietary technologies in carbonated gas packs, microneedles, hydrogen products, scrubs, and femcare products, and also handles specialized filling processes.
Not sure which manufacturer is best for you?
OEM JAPAN's team provides free consultation support. Tell us what you're looking for and we'll help.
A pioneer in aerosol cosmetics manufacturing, established in 1948. Handles OEM contract manufacturing of aerosol products and hair care cosmetics including hair spray, styling products, perm solutions, and hair color. Owns an ECOCERT-certified aerosol factory.
An ODM/OEM cosmetics manufacturer established in 1961, part of the Chanson Cosmetics Group. Caring Japan was the first in Japan to obtain Ecocert factory certification, and handles products ranging from COSMOS-compliant organic cosmetics to quasi-drugs. The company operates an integrated system from raw material development to manufacturing.
Key regulations and requirements for importing Quasi-Drug from Japan
Japan's 'quasi-drug' (医薬部外品) category does not exist in US law. Products may be classified as either OTC drugs or cosmetics depending on their claims and active ingredients. Medicated shampoos, sunscreens, and anti-acne products typically fall under OTC drug regulation.
Determine whether the product will be marketed as an OTC drug or cosmetic in the US. Prepare appropriate documentation including product formulation, efficacy data, and safety data.
Ministry of Health, Labour and Welfare (MHLW)
If classified as an OTC drug, the product must comply with applicable FDA OTC monograph (e.g., sunscreen monograph, acne monograph). Active ingredients must be listed in the monograph at specified concentrations.
Food and Drug Administration (FDA)
OTC drug manufacturers must register with FDA as a drug establishment and list all products. This is separate from the cosmetics registration under MoCRA.
Food and Drug Administration (FDA)
OTC drugs require a 'Drug Facts' panel listing active ingredients, uses, warnings, directions, and inactive ingredients in a specific format.
Food and Drug Administration (FDA)
Japanese quasi-drugs that make medicinal claims (whitening, hair growth, anti-dandruff) will likely be classified as OTC drugs in the US, requiring monograph compliance or an NDA. Reformulation may be necessary if the active ingredients are not in FDA OTC monographs.
6-18 months (classification determination, monograph compliance, possible reformulation, FDA registration)
Japan's quasi-drugs with cosmetic functions (whitening, sunscreen, anti-hair loss) are classified as 'special cosmetics' (特殊化妆品) in China, requiring full NMPA registration — a significantly longer and more expensive process than general cosmetics filing.
CFS plus detailed product documentation including full formula, manufacturing process, and efficacy/safety data required for NMPA registration.
Ministry of Health, Labour and Welfare (MHLW)
Special cosmetics (whitening, sunscreen, hair dye, hair perm, anti-hair loss, breast care, body odor) require NMPA registration. This includes technical review, human safety and efficacy testing, and expert panel review.
National Medical Products Administration (NMPA)
Special cosmetics require more extensive testing than general cosmetics, including SPF/PA testing for sunscreens, human patch tests, and efficacy evaluation.
National Medical Products Administration (NMPA)
NMPA special cosmetics registration typically takes 12-24 months. The process includes: sample preparation and submission, lab testing (3-6 months), technical review (3-6 months), and administrative review. Budget $30,000-$80,000+ per product.
Some Japanese quasi-drugs can be reformulated or repositioned as 'general cosmetics' in China by removing medicinal claims or active ingredients. This avoids the lengthy special cosmetics registration. Consult with a Chinese regulatory specialist.
12-24 months for special cosmetics registration
This information is provided for reference purposes only and does not constitute legal advice. Regulations may change. Please consult with qualified trade compliance professionals for your specific situation.