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Regulatory, NPRA & global registration

Registered to sell —
here and abroad.

Regulatory registration is what makes a supplement legal to sell: an NPRA notification and MAL number for Malaysia, a Certificate of Free Sale for export, and a separate filing in every other market. NaViBiotech prepares the dossier, makes the submission and manages the process through to approval. That covers Malaysia plus 24 export markets, working with each local health authority or FDA.

What we can do /Regulatory & registration

Product registration: mandatory to sell

A product you cannot register is a product you cannot sell.

A finished product still cannot be sold until it is registered — and every market has its own authority, dossier and rules. We handle the regulatory path end-to-end: NPRA notification and your MAL number in Malaysia, the Certificate of Free Sale for export, and product registration in 24 markets with each local health authority or FDA. You get a product that is legal to sell, not just made.

Kami menguruskan pendaftaran produk anda di Malaysia — notifikasi NPRA, nombor MAL dan Sijil Jualan Bebas (CFS) — serta pendaftaran di 24 pasaran eksport dengan pihak berkuasa kesihatan tempatan.

NPRA notification & MAL number

We prepare the dossier and register your product with the NPRA to obtain the MAL number that makes it legal to sell in Malaysia.

Certificate of Free Sale

The export document overseas regulators require before your product can enter their market.

Registration in 24 markets

We register your product with each export market's local health authority or FDA — full legalisation, not just shipping.

Dossier preparation

Formulas screened against prohibited and controlled lists, with the documentation each authority expects.

Label & claim compliance

We confirm your labelling and claims meet each market's rules before submission.

Trusted in 50+, registered in 24

We have shipped to clients in 50+ countries; for 24 markets we provide full local product registration.

Certifications: GMP, ISO 22000, HACCP and JAKIM Halal

The group edge, on every order.

JAKIM-certified halal

Every product runs through a JAKIM-recognised halal system — the credential that opens Malaysia, the GCC and the wider Muslim market without a second audit.

Two origins, one standard

The same formula runs in Malaysia and in China to the same GMP and ISO 22000 spec. Take a Malaysia country-of-origin to hedge US–China tariffs, or balance cost and capacity across both.

Flexible MOQ

We size the minimum order around your launch, not the other way round. Start small to prove the market, then scale the product line as demand shows up.

Trusted by clients in 50+ countries

One team takes you from formula and design through NPRA registration and Certificate of Free Sale — with full product legalization in 24 markets, and clients in 50+ countries.

NPRA dossiers, MAL numbers and export registration

Built to clear the first time.

We screen the formula against prohibited and controlled-ingredient lists and prepare the dossier each authority expects — so registration goes through cleanly, locally and for export.

See the brands we build →

What you can rely on

  • GMP- and ISO 22000-certified production
  • In-house formulation & stability testing
  • NPRA registration + Certificate of Free Sale
  • Your formula, your IP, never resold

How the OEM process works, from idea to shelf

Three steps from idea to shelf.

See the full 11-step process →
01

Tell us the idea

Share the product, the market and your budget. A mutual NDA is in place from the first message — your concept stays yours.

02

We formulate & sample

We propose a formula, or adapt a proven one, cost it clearly, and produce a trial for you to taste, feel and approve.

03

We register & make

We handle NPRA registration and your Certificate of Free Sale, then manufacture to GMP and ship — locally or to 50+ export markets.

Frequently asked questions about OEM manufacturing

Questions, answered.

What is a MAL number and do I need one? +

A MAL number is the registration number the NPRA issues to a notified product. You need it to sell a supplement legally in Malaysia, and we handle the registration that obtains it.

Do you handle NPRA registration for me? +

Yes — end-to-end. We prepare the dossier, make the submission and manage the process through to your MAL number.

What is a Certificate of Free Sale? +

An official document confirming your product is approved for sale in Malaysia. Overseas regulators ask for it before allowing the product into their market, and we secure it for you.

Can you register my product in other countries? +

Yes. Beyond Malaysia, we provide full product registration in 24 export markets, working with each local health authority or FDA.

How long does NPRA registration take? +

It varies by product class and authority workload. We prepare a complete, compliant dossier up front, which is the main lever for avoiding delays.

Which markets can you register in? +

Malaysia, plus 24 export markets with full local registration and services. We have shipped to clients in 50+ countries in total.

More ways we can help

Three GMP-certified factories in Malaysia and China

Three factories. Real addresses. One standard.

Plant I · Malaysia

Seri Kembangan, Selangor

Cyto Tech Sdn Bhd

11, Jalan Perindustrian Balakong Jaya 2/3, 43300 Seri Kembangan, Selangor

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Makes

Granule & powder functional food — instant coffee & tea, meal replacement, collagen drink.

GMP (PIC/S) HACCP ISO 22000 Halal (JAKIM)

Plant II · Malaysia

Balakong, Selangor

Cyto Tech Wellness Sdn Bhd

54, Jalan Taming 8, Taman Taming Jaya, 43300 Balakong, Selangor

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Makes

Powder, chewable-tablet & capsule supplements. Pharma-licensed for NPRA-registered and traditional medicines.

GMP (PIC/S) HACCP ISO 22000 Halal (JAKIM)

Plant III · China

Guangzhou, China

CytoTech Guangzhou

Xitian Science Park, No. 36, Bowen 2nd Street, Huangpu District, Guangzhou

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Makes

Overseas production and sourcing for export programmes.

GMP (PIC/S) HACCP ISO 22000 Halal (JAKIM)

Combined annual capacity exceeding 500 million units across powder, tablets and capsules. Our Malaysian plants are Halal-certified, and we provide Halal application and certification as a service.

Need to get registered?

Tell us your product and target markets — we will map the registration path and handle it.

Last reviewed 12 September 2026 · YB Leo, Founder