Registered Malaysia (MAL)

Registration BPFK (MAL & NOT) Product

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BPFK Registration (MAL)

Our experience in registering products ranging from product gazetting into the food act to supplement (MAL), traditional (MAL), cosmetics (NOT) and food products registrations.

Submission to the Ministry of Health for classification.

Classifications are based the submitted packaging and ingredient list.

It is the first step before more in-depth details are required.

Traditional products are products which have been traditionally used for a set of preapproved claims with exceptions of claims which have significantly strong science to validate its claim.

This category includes non-edible products such as balms and creams as well as edible products in liquid, powders and capsule forms.

Cosmetics are products which do not have any indications for health benefit use on packaging as well as advertising materials. These products are usually solely for external use only.

The company or person responsible for placing a cosmetic product in the local market must notify the Director of Pharmaceutical Services (DPS) through the National Pharmaceutical Control Bureau (NPCB) prior to market, manufacture or import a cosmetic product. This notification process will allow the NPCB to gather adequate information on the cosmetic products that are placed in the local market.

It is an offence for anyone to manufacture or import a cosmetic product without prior notification to the DPS.

Supplements are products which are intended to “supplement” the diet taken in forms such as pills, capsules, tablets, liquids or powders and not represented as a conventional food or as a sole item of a meal or the diet.

As active ingredients found in the product increase so does the cost due to the increased complexity of evaluation.

Food – as defined under the Food Act 1983 and Food Regulations 1985, includes every article manufactured, sold or represented for use as food or drink for human consumption or which enters into or is used in the composition, preparation, preservation, of any food or drink and includes confectionery, chewing substances and any ingredient of such food, drink, confectionery or chewing substances. This includes food for special dietary use for persons with a specific disease, disorder or medical condition, and food which contain quantities of added nutrients allowable under the Food Act and Regulations.

* For information on Food refer to – Drug Intephase products, please refer to subtitle ‘Regulatory Information’ > ‘Other guidelines’ > ‘Classification decision tree’ for further details.

What products are required to be registered?

  1. Pharmaceutical products containing scheduled poisons.
  2. Pharmaceutical products containing non-scheduled poisons (OTC)
    Includes:
    + Medicated plaster with medicines
    + Antiseptic/ Disinfectants for use on the human body
    + Diagnostic agents for human use (in vivo)
    + Dietary supplement e.g. Probiotics, Chitosan
  3. Traditional products
    Includes:
    + Homeopathic medicines
    + Ayurvedic medicines
    + Medicated plaster
    + Herbal teas
    + Dietary supplements eg. Spirulina, Chlorella, Royal Jelly, Bee Pollen, Aloe Vera juice, Noni juice, Extract of chicken with herbs
  4. Veterinary products
    Includes:
    + Oral solution, oral suspension & emulsions
    + Granules
    + Paste
    + Water soluble powder
    + Injectable
    + Powder for injection
    + Oral powders
    + Capsule, tablet
    + Topical ophtalmic and otic products
    * Guidance Decision Tree

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We will reply your emails within 24 hours, upon receiving your query.
You can also email us directly at support@furleybio.com

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Capsule

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Capsule

Our capsule service includes support on registration and process optimization as well as advice for capsule manufacturing of products.

Existing wise we have a complete semi-automatic capsule line, but we do outsource capsule projects due to the competitive nature of capsule.
From powder stability, excipients, polishing, quality inspection, packaging material & packaging label compliance.

Capsule Services

Moisture Analyser (In-house)

The ability to run moisture analysis ad-hoc allows us to cross-validate parameters which ensure environmental and product stability is achieved.

Ideally packed products should maintain a <8% water activity, ensuring microorganism spoilage is managed.

ATP Cleanliness Testing

We use 3M Clean-Trace ATP testing protocols to ensure our manufacturing line is cleaned till there are no chances of cross contamination. This eliminates possibilities of microorganism spoilage. It is considered expensive but we believe in delivering the highest level of manufacturing services to our customers.

Formula

Our knowledge in formulating products enables us to understand possible failures which can occur from existing formulations. We strive to achieve total customer satisfaction in both service and products they manufacture with us.

Packaging and Labelling Compliance

Based on our experience we provide input for packaging material selection as well as labeling compliance with Ministry of Health Malaysia.

Capsule Dissolving Ability

In-house we have are able to measure the time required for a capsule to be dissolved.

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We will reply your emails within 24 hours, upon receiving your query.
You can also email us directly at support@furleybio.com

Traditional Semi-Solid Formulation

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Traditional Semi-solid Formulation

We are able to create a variety of creams based on our customers required performance, viscosity, color and mode of delivery.
Our expertise has developed all natural cream bases as well as conventional oil in water emulsions.

Our library of premium grade essential oils creates a lasting premium impression on customers whilst still remaining competitively priced.

extra Services

Viscosity

The study of Rheology allows us to understand the behaviour of creams under parameters such as temperature. Having a thorough understanding of how the product performs in a day to day scenario.

Fragrance

Our range of natural essential oils ensures your product is not only premium but safe. The stability and use of premium safe essential oils not only appeases the conscious it also allows customers to create a signature smell only unique to their product.

Apperance

Perception of the cream color has shifted from white to clear to all natural colors for creams. Whatever your demands are we are able to cater to your color demand needs.

Absorption / Play Time / Finishing

Require a low play time? perceived to be absorbed fast? or long play time perceived to have better value – premium?

Our in-house research & development are able to cater to all your requirements and needs. Having a higher water content or vice versa with oil phases.

All this whilst ensuring product stability without seperation issues.

   Drop A line Here

We will reply your emails within 24 hours, upon receiving your query.
You can also email us directly at support@furleybio.com