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Derigin Industries Inc. • Manufacturing FAQ

Questions before you build your brand?

Explore common questions about OEM/ODM manufacturing, FDA requirements, cGMP, formulation, production, packaging, quality, and market readiness.

FDA-Licensed ManufacturerRegulated manufacturing establishment
cGMP OperationsManufacturing under applicable cGMP requirements
End-to-End SupportFormulation • packaging • regulatory • production
Showing 28 of 28 questions
01 I’m new to the skincare or nutraceuticals business. Where do I start? Getting Started
Start by choosing the development route that fits your business:
  • White Label: choose from ready-developed products for a faster launch.
  • ODM: bring us your product concept and we develop the formulation with you.
  • OEM: you provide or own the formulation and we manufacture it for you.
We can then assist with product selection, formulation, packaging, labeling, regulatory requirements, and production.
02 Do I need my own factory to launch my brand? Getting Started
No. You can launch your own brand without owning a manufacturing facility. As an FDA-licensed manufacturer, Derigin Industries Inc. can manufacture for your brand through OEM, ODM, private-label, or white-label arrangements.
03 What’s the difference between OEM, ODM, private label, and white label? Getting Started
  • OEM: you own/provide the formula or technical specification; we manufacture.
  • ODM: you provide the concept or target product; we assist in developing and manufacturing it.
  • Private Label: the product is manufactured for sale under your own brand.
  • White Label: a ready-developed product is offered to multiple clients for branding, usually providing the fastest route to market.
04 Do I need FDA authorization before I can sell my product? Regulatory
For regulated products in the Philippines, the appropriate FDA authorization must be secured depending on the product category. Cosmetics generally require the applicable product notification, while food supplements and other regulated food products may require the applicable product registration. We can assist clients in identifying the appropriate regulatory pathway for their product.
05 What’s the difference between LTO, CPN, and CPR? Regulatory
  • LTO — License to Operate: authorization for the regulated establishment or company to perform its licensed activity.
  • CPN — Certificate of Product Notification: used for cosmetic product notification.
  • CPR — Certificate of Product Registration: used for applicable regulated product categories that require product registration, such as certain food and food-supplement products.
Regulatory requirements depend on the final product classification. Our team can provide documentation and filing assistance as a value-added service.
06 Can you assist with FDA documentation and licensing? Regulatory
Yes. We provide in-house regulatory assistance for applicable product documentation, label review, product notification/registration support, and other FDA-related requirements within the scope of the project. Government fees and third-party testing costs, when required, are charged separately unless included in a written package quotation.
07 Do you have cGMP? cGMP & Quality
Yes. Derigin Industries Inc. is an FDA-licensed manufacturer and our manufacturing operations are conducted in accordance with applicable current Good Manufacturing Practice (cGMP) requirements. cGMP forms part of the quality and manufacturing controls expected of licensed manufacturers and is implemented through documented procedures, sanitation and hygiene controls, personnel practices, production controls, traceability, quality checks, and regulatory inspection requirements.
Important distinction: We describe our operations as FDA-licensed and operating under applicable cGMP requirements. A separate third-party “cGMP certificate” should only be claimed when a specific certification has actually been issued by the relevant certifying body.
08 Are you GMP- or cGMP-compliant? cGMP & Quality
Yes. As an FDA-licensed manufacturing establishment, we operate under applicable cGMP requirements for the product categories we manufacture. Our quality system includes controlled manufacturing procedures, batch documentation, sanitation and hygiene programs, raw-material and packaging controls, in-process checks, finished-product checks, and traceability.
09 How do you ensure product quality? cGMP & Quality
We combine cGMP-based manufacturing controls with documented procedures and batch-level quality checks. Depending on the product, controls may include incoming-material review, weighing and dispensing controls, in-process monitoring, packaging checks, batch documentation, finished-product evaluation, and third-party laboratory testing when required.
10 Do you provide a Certificate of Analysis (COA)? cGMP & Quality
Yes. We can issue an in-house batch COA or quality document for internal/reference use based on the tests and controls performed for the batch. When an independent or accredited laboratory report is required for regulatory, export, tender, retail-chain, or client-specific purposes, third-party testing can be arranged at additional cost and lead time.
11 Do you provide safety, stability, or laboratory testing? cGMP & Quality
Yes. Testing requirements depend on the product and project scope. We can perform or coordinate appropriate product-development checks and arrange third-party laboratory testing when official, independent, or specialized results are required. Applicable laboratory fees and lead times are quoted separately.
12 Can I customize my product’s ingredients, scent, color, or texture? Formulation
Yes. Customization can include active ingredients, botanical extracts, flavor or fragrance systems, color, texture, viscosity, delivery format, and other product attributes—subject to ingredient compatibility, safety, stability, regulatory limits, and manufacturing feasibility.
13 Can you develop a product from my concept? Formulation
Yes. This is part of our ODM / product-development service. You may provide the product idea, target market, desired benefits, benchmark product, preferred ingredients, price target, and packaging concept. We then help translate the concept into a manufacturable formulation and product specification.
14 Can you make natural, plant-based, vegan, cruelty-free, or organic-positioned products? Formulation
We can develop formulations around natural, plant-derived, vegan-suitable, or other requested ingredient-positioning strategies when technically and commercially feasible. However, terms such as certified organic, certified vegan, or certified cruelty-free should only be used when the applicable certification and supporting documentation have actually been obtained. Third-party certifications can be explored as a separate client-funded project.
15 Can I change my formula in future production runs? Formulation
Yes. A formula can be revised, but changes may require new sampling, compatibility/stability checks, updated costing, label revisions, and—depending on the nature of the change—updated regulatory documentation or a new product filing.
16 What is your minimum order quantity (MOQ)? Production
MOQ depends on the formulation, dosage form, packaging, filling requirements, raw-material minimums, and degree of customization. As a general guide, some skincare projects can begin at relatively low quantities, while nutraceuticals, sachets, capsules, and highly customized packaging may require higher minimums. We confirm the actual MOQ after reviewing the product brief.
17 How long does product development and production take? Production
Lead time depends on whether the project is white label, customized, or fully developed from concept. It may include formulation, sampling, client approval, sourcing, packaging, regulatory work, testing, and production scheduling. Reorders are normally faster once the formula, materials, artwork, and packaging specifications are already approved and available.
18 Do you provide product samples before mass production? Production
Yes. Depending on the project, we can prepare bench samples, development samples, or pilot quantities for client evaluation before commercial production. Sample fees may apply for custom development, specialty actives, imported materials, or multiple revisions.
19 Can I supply my own raw materials or packaging? Production
Yes, subject to our acceptance criteria. Client-supplied materials and packaging must be suitable for the intended product, properly documented where applicable, and compatible with our manufacturing and quality requirements. We may request specifications, COAs, safety documents, or samples for evaluation.
20 How is pricing determined? Pricing
Pricing depends on the formula, active ingredients, raw-material grades, packaging, print and labeling requirements, order volume, dosage form, testing, product-development work, and regulatory scope. We provide project-specific quotations because two products with the same size can have very different manufacturing costs.
21 Do you require a down payment? Pricing
For production projects, our standard commercial arrangement may require a 50% down payment to initiate procurement and production, with the balance due according to the approved quotation or agreement before release. Final payment terms are stated in the formal project quotation.
22 Are FDA and laboratory fees included in the manufacturing price? Pricing
Not automatically. Government filing fees, third-party laboratory fees, specialized testing, certification fees, and other external regulatory expenses are normally separate unless they are expressly included in a bundled quotation.
23 Do you provide packaging and label design? Packaging & Branding
Yes. We can assist with packaging sourcing, label layout, artwork preparation, product information panels, and label-content review. Final artwork and claims must remain consistent with the approved formulation, product classification, and applicable regulatory requirements.
24 Can I bring my own packaging? Packaging & Branding
Yes. Client-supplied packaging can be accepted after checking compatibility with the product and our filling or packing process. We recommend evaluating packaging early because bottle, closure, sachet, jar, pump, and label specifications can affect production, stability, appearance, and cost.
25 Can you help build my brand, not just manufacture the product? Packaging & Branding
Yes. Derigin Industries combines manufacturing experience with practical brand-development and retail experience. Depending on scope, we can assist with product positioning, naming direction, packaging presentation, label design, product photography, market-ready presentation, and launch materials in addition to manufacturing.
26 Can I sell online without a physical store? Market & Export
Yes. Many new brands launch through their own websites, social media, marketplaces, distributors, or reseller networks. Your selling channel does not remove the need to comply with the applicable product, labeling, advertising, and regulatory requirements.
27 Can you manufacture products intended for export? Market & Export
Yes. We can manufacture products intended for local and export markets. Export requirements vary by destination, so the client and manufacturer should review the target country’s ingredient restrictions, product classification, labeling, documentation, testing, and importer requirements before finalizing the product.
28 Do you help with marketing? Market & Export
Our core business is product development and manufacturing, but we also understand brand-building and retail execution. Marketing-related support may include product presentation, packaging design, product photography, basic launch materials, and referrals or collaboration with specialist partners depending on the project.
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