FDA License for Cosmetics Manufacturing
All cosmetics manufacturers in the Philippines must hold a valid FDA License to Operate (LTO) in the cosmetics category. The FDA LTO ensures manufacturers meet Good Manufacturing Practices and safety standards. Orsolab holds FDA Cosmetics LTO No. LTO-3000006301418. See FDA Registration Cosmetics Philippines.
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LTO Requirements: GMP-certified facility, qualified technical personnel (licensed chemist or pharmacist), proper equipment and infrastructure, quality control systems, sanitation and hygiene protocols, product safety documentation
GMP Certification: Required before FDA LTO application. Third-party GMP audit of facility, equipment, processes, documentation systems. Valid 3 years.
Application Process: Submit application to FDA Center for Cosmetics Regulation, provide GMP certificate, facility plans, equipment list, personnel qualifications, quality control procedures. FDA conducts facility inspection. LTO valid 2 years, renewable.
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Timeline: GMP certification 2-4 months, FDA LTO application 2-3 months after GMP. Total 4-7 months for new facilities.
Costs: GMP certification ₱50,000-₱150,000 depending on scope. FDA LTO application fees ₱5,000-₱15,000. Does not include facility construction, equipment, or infrastructure investment.
For brands: Partner with FDA-licensed manufacturers rather than building own facility. Orsolab manufactures for brands under our FDA Cosmetics LTO. See Contract Manufacturing, Private Label Manufacturing.
Submit inquiry to discuss manufacturing partnership.
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FAQs
Can I manufacture cosmetics without FDA LTO?
No. Manufacturing cosmetics without FDA LTO is illegal and subject to closure, fines, and product seizure. All manufacturers must hold valid LTO.
How long is FDA LTO valid?
FDA Cosmetics LTO is valid for 2 years and must be renewed before expiration. GMP certification valid 3 years.
Can brands use manufacturer's FDA LTO?
Yes. Brands partner with FDA-licensed manufacturers who produce under their LTO. Brands own the finished products and register them under FDA Product Notification.