Browse Quasi-Drug (Iyakubugaihin) cosmetics OEM manufacturers in Japan. Find contract manufacturing partners. Filter by small lot options and sample availability. Free consultations available.
製造許可
医薬部外品製造業許可の取得は必須。製造販売業許可も併せて持っていると承認手続きがスムーズです
承認取得サポート
新規処方の医薬部外品承認取得をサポートしてくれるかどうかは、初めてのOEMでは特に重要です
有効成分
美白・育毛・制汗・殺菌など、目的に合った有効成分の取り扱い実績と処方開発力を確認しましょう
品質認証
GMP認証の取得、安定性試験・安全性試験の自社対応が可能かを確認しましょう
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 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."
Cosmetics OEM manufacturer with headquarters and directly operated factory in Ehime, established in 1985. Has planned and manufactured a wide range of products for over 35 years, centered on face masks, including skincare cosmetics, beauty miscellaneous goods and beauty devices. ISO 9001 certified. Part of RIZAP Group. Provides one-stop support from planning, design through shipping.
Fukuoka cosmetics and quasi-drug manufacturer established in 1960 (predecessor founded in 1887). Provides integrated response from R&D of beauty ingredients (cosmetic raw materials) through cosmetics manufacturing and sales. Strength is ODM proposal capability leveraging experience of developing original brands such as 'Dermed'. ISO 9001 and ISO 22716 certified. 102 employees.
Established in 1999. Specializes in OEM manufacturing without holding an original brand. Carefully selects over 80 domestic natural ingredients on a proprietary basis, succeeded in developing the world's first plant-based human-type ceramide (patented). Conducts over 100 safety and efficacy evaluation tests. 147 employees.
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.
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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.
Cosmetics OEM division of Cosmetex Roland. Supports planning, R&D, manufacturing and sales of cosmetics and quasi-drugs including skincare, haircare, disinfectants and mouthwash. Directly operated factory in Narita City, Chiba Prefecture. Rich track record of overseas expansion.
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.
Established in 1954, a Shiseido Group company specializing in milled transparent soap and cleansing products. Leveraging over 70 years of R&D and production expertise, the company operates OEM/ODM services. It handles contract production of various facial cleansers, body washes, and hair care products.
A cosmetics and quasi-drug OEM specialist manufacturer founded in Kyoto in 1953. With its main production base at the Kobe Sanda Factory, Celless is a comprehensive contract manufacturer with planning, development, and manufacturing experience spanning thousands of product items. The company also handles health food OEM.
Cosmetics OEM manufacturer founded in 1978. Has an ISO 9001 / ISO 22716-certified directly operated factory in Narita City, Chiba Prefecture, providing integrated system from planning and development through manufacturing of basic cosmetics, haircare, bodycare and quasi-drugs. Also develops many original brands.
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 and quasi-drug OEM contract manufacturer established in 2002. Handles all body care products including hair removal creams, deodorants, hand creams, and body soaps. Has delivery track records across diverse sales channels including TV shopping, variety shops, and hotel amenities.
A quasi-drug and cosmetics manufacturer established in 1988, headquartered in Miyazaki City, Miyazaki Prefecture. Has conducted long-term research on the medicinal plant 'Calanthe discolor' (Ebine orchid), obtaining patents in 13 countries for blood flow promotion and hair growth effects. Has a track record of OEM manufacturing over 6 million bottles of Ebine orchid extract hair growth products.
An OEM cosmetics manufacturer founded in 1986, currently headquartered in Kan'onji City, Kagawa Prefecture. The company specializes in the production of sheet-type products such as face masks and cleansing sheets. It has obtained ISO 9001 and ISO 14001 certifications and also handles quasi-drug manufacturing.
A contract manufacturer of quasi-drugs and cosmetics centered on bath products, established in 1940. Equipped with facilities specializing in powdered bath products and bath cosmetics, handling everything from small to large lots. Maintains rigorous quality control at its GMP-certified factory.
Cosmetics and quasi-drug contract research and manufacturing company founded in 1986, with a track record of approximately 1,100 cosmetics development projects. Strength is distinctive cosmetic development applying the worldwide-patented 'Lamellar Technology'. Ultra-small lots of 100 lotion bottles / 100 hand creams supported, and safety testing also conducted in-house.
A long-established manufacturer founded in 1855, producing bath additives since 1933. Known for manufacturing and selling the medicated bath additive "Onsen-su" (quasi-drug). Handles manufacturing of diverse bath additives including powders, liquids, tablets, gels, scrubs, and bath salts, offering OEM contract manufacturing utilizing natural ingredients.
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OEM JAPAN's team provides free consultation support. Tell us what you're looking for and we'll help.
A cosmetics contract manufacturer founded in 1951, capable of integrated production from functional powder raw material sales to intermediate and final products. Starting from raw material development, the company provides comprehensive services including formulation, product commercialization, and quality assurance. It has a factory in Yaita City, Tochigi Prefecture, and operates production bases in Japan, China, and Singapore.
A pharmaceutical company founded in 1935. The company develops products across four categories: pharmaceuticals, cosmetics, health foods, and alcoholic beverages. Leveraging production expertise cultivated over its long history, the company has recently focused on OEM/ODM operations. Its strengths include small-lot production that large companies find difficult to accommodate, and formula development based on attentive client consultations.
Key regulations and requirements for importing Quasi-Drug (Iyakubugaihin) 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.