1) What dosage forms does Rhema manufacture?
Rhema manufactures exclusively dry dosage forms, specifically 2-piece hard shell gelatin or vegetarian capsules, powders, and tablets including chewables, lozenges and sub-linguals. We also offer a proprietary GRAS-affirmed aqueous based enteric coating for soft gelatin capsules and tablets, as well as standard coating for tablets to produce an aesthetically pleasing shiny appearance and to facilitate ease of swallowing, and delayed-release coating enabling products to release activity for up to a six hour period.
2) What dosage forms does Rhema Package?
Rhema packages powders, tablets, capsules and soft-gelatin capsules.
3) What services does Rhema offer?
We offer: blending of powders, encapsulation in 2-piece gelatine or vegetable capsules, coating and enteric coating for tablets and soft-gelatin capsules and packaging and labelling. Our powder filling capabilities include jars and canisters, single-dose stick packs and sachets as well as soft plastic gusset bags. We are also able to fill multiple tablets and capsules into cellophane single-dose packets.
4) What regulatory compliances does Rhema hold?
We are:
- Certified GMP compliant and Establishment licensed (# 100228-A) by Health Canada for the fabrication and packaging of drug (DIN) products.
- Site licensed (# 300704) for natural health products (NHP).
- Precursor A licensed (# 9-0291-2010) for the manufacture and packaging of ephedrine and pseudo-ephedrine.
- TGA approved for the fabrication of therapeutic goods in Australia.
- The FDA issued an Establishment Inspection Report in July 2011 to RHPL for Food and Dietary Supplements, and no FDA 483 Report was filed
- Organic certified through QMI (1621868) for the manufacture and packaging of specific organic products.
We can obtain kosher certification for specific production
runs, as required.
5) Do you manufacture all products in Canada?
We manufacture powders, capsules and tablets from our headquarters in British Columbia, Canada. We have entered into a partnership for powder blending from Utah, USA. Additionally, Rhema Health Products USA Inc. opened it`s doors in Dec. 2011 and is a state of the art packaging facility. We are able to package powders in jars, canisters and sachets, tablets and capsules from this facility.
6) Do you specialize in anything?
We are experts in flavouring powder drink mixes and chewable tablets. Botanical preparations, B vitamins, and green superfoods are especially challenging to flavour. We have extensive experience making these ingredients and many others taste good! Our product development experts and sales & marketing teams keep their fingers on the pulse of the natural products industry, and we are very proactive in helping our customers achieve best-in-class products. Rhema is one of the only pure-play contract manufacturers in North America to be able to manufacture health products and dietary supplements in both the USA and Canada.
We are also known for our coating capabilities. We offer standard coating (releases within one hour), delayed-release coating (releases for up to a six hour period), and GRAS-affirmed aqueous-based enteric coating (releases in the intestine). Coating, whether enteric, standard or delayed-release makes a tablet appear shiny, improves shelf-life and facilitates easier swallowing. For soft-gels and tablets, enteric coating protects the shell or core from disintegrating in the stomach allowing the contents to release in the small intestine, the primary site of absorption for many nutrients.
7) How do you work with difficult materials?
Before a production batch is conducted, we evaluate the physical properties of the ingredients for parameters such as flowability and density as well as particle size and shape. Our team of technical experts makes a determination whether the ingredients can be mixed dry or whether wet granulation is required and in what type of blenders the ingredients will be mixed. We also consider other factors such as the time required for blending without causing particle separation or over mixing, the fill level of the blender, and the order of adding each ingredient.
When required, we employ various processes to prepare the ingredients for blending, compression or encapsulation.
Some of the processes we utilize to bring materials into a production-ready state include:
Milling, which will provide a consistent particle size
Granulation, which will form granules
Chilsonation, which will increase density
Trituration, which will intersperse the actives in a diluent to increase the surface area of the actives
Ideally, all materials would be received already in a free-flowing, production-ready state; however this is not always possible. When materials are difficult to work with, you can rely on Rhemas experience, quality and innovation to find the best manufacturing solution.
8) What types of products does Rhema manufacture?
We make a wide variety of products including: multivitamins & minerals, herbal combinations, fiber products, green superfood blends, protein powders, meal replacement supplements, energy formulas, diet products, enzymes, probiotics, and condition-specific products. We also offer multiple varieties of coating for tablets and soft-gels, including; standard coating (releases within one hour), delayed-release coating (releases for up to a six hour period), and GRAS-affirmed aqueous-based enteric coating (releases in the intestine).
Ask us about manufacturing your unique formula!
9) What are your minimum order requirements?
Powder: 500 kg
Capsules: 200,000 capsules
Tablets: 200,000 tablets
Coating: 150 kg of tablets/capsules/softgels
Minimum order requirements are negotiable for certain products. Ask your Rhema Account Executive for further details.
10) What are your lead times?
Lead times vary significantly based on many factors, including:
- the complexity of the product(s) and availability of the raw materials
- the number of products required
- whether product development is required
- the QC testing required
- whether products are being produced for the first time or are repeat orders
- whether they are to be shipped in bulk or packaged
- what our existing production commitments are at the time you place your order
Products being produced for the first time that require extensive product development require a 6 month lead-time to finished product; this represents roughly a 10-12 week development process followed by a 12 14 week production schedule.
Typical lead times for repeat orders vary depending on the availability of the raw materials. We require 6 8 weeks from the time of receipt of all raw materials to produce a quality tested, finished product with accompanying certificate of analysis. Speak to your Account Executive regarding other documentation you may require.
Other factors that can affect lead time are the timing of your sign-off on the Rhema sales order, any required deposit or receipt of your labels and other packaging components.
11) Can we provide our own raw materials?
Yes, provided they comply with the raw material agreed specifications between you and Rhema and any necessary indemnities are in place.
12) What size capsules and tablets can you manufacture?
We manufacture with capsules (gelatin or vegetarian) in the following sizes organized from smallest to largest:
#3, #2, #1, 0 and 00.
We manufacture tablets in a wide range of sizes and shapes including: Ό round to 7/8 round, ½ X Ό caplet, Ύ X 5/16 caplet, 5/8 X 5/16 oval, 7/8 X 3/8 oval and many more.
We will work with you to size your product appropriately. Unique punches and capsule printing is available at a premium.13) Do you sell your own branded products?
No. At Rhema, we focus our efforts exclusively on working with our customers to produce innovative, quality products for them to market under their own labels. Likewise, through our affiliate company, Rhema Innovations Limited, we make available to our customers unique, exclusively Rhema developed, state-of-nutritional-science formulations (for license or sale) to market under their own label(s).
14) Who do you manufacture for?
We work on the basis of non-disclosure agreements with our clients. Accordingly, except by special permission we are unable to provide customer names. We are proud to say that several of our customers have been with us for 10 years or more and that our integrity, innovation and experience have secured us manufacturing partnerships with industry leaders in Canadian, US and international markets.
15) Do you have enough capacity to fulfill my orders as my business grows?
We have recently greater than doubled our capacity through our US partnership and the addition of a new two tonne ribbon blender. We continue to build capacity in our other dosage forms as required and have expanded our capabilities to include sachets, stick-packs and soft plastic gusset bags. Many of our customers have experienced continuous double digit growth including periods of explosive growth, and we have consistently been able to keep pace with their needs. When you partner with Rhema for your manufacturing and packaging needs, you can rest assured that we have planned for growth and have the experience to handle the welcome challenges that accompany your growth.
16) What types of packaging do you offer?
We package in a variety of materials including HDPE, PET and PS bottles or jars, and re-sealable gusset bags. A variety of film types can be used in the production of stick-packs and cellophane type film for our multi tablet-capsule sachets. Packaging is available in a variety of styles and colors including child resistant and tear-away. We can fill bottles ranging in size from 60cc to 5 litres.
17) Can I provide you with my artwork for labels and/or cartons?
No. Customers are responsible for providing their own labels. We have close relationships with several printers that have many clients in the nutraceutical industry, to which we can refer you.
18) Will you proof my label for me?
Rhema is responsible for proofing the following two label parameters only: the name of the product (i.e. to confirm that the product is correctly identified and the quantity per bottle. You are ultimately responsible for the accuracy of your label. You are required to sign a Master Label Specification confirming that the label is approved for use. Any time you make any changes to your label, you will need to sign a new Master Label Specification, and provide formal authorization for the removal of your current labels from our active inventory. If we become aware of any inaccuracies on your label, we will of course bring this to your attention; however this courtesy should not be construed as extending Rhemas responsibilities beyond the two label parameters noted above.
19) How long will it take you to send me a quotation?
The turn-around on a quotation depends on many factors. First, our formulators review your formula to determine whether it will achieve your desired product parameters or they develop a formula from your product concept. Often there are several iterations required to fine tune and arrive at a final formula. Once the formula is finalized it is sent to our costing department to create a cost estimate. The estimate is based on the price of the raw materials, production costs, and packaging costs, if applicable. If the formula has a large number of materials or the materials are particularly unusual or unique we will need to confirm current pricing with our raw material suppliers or find a source for the new materials and obtain pricing and specifications. Once the cost estimate is complete, it is reviewed by the appropriate departments before being sent to your Rhema Account Executive for final review and quotation. The process of creating a formula, cost estimate and quotation can take as little as one to two days or up to three weeks. When you request a price your Rhema Account Executive can give you an approximate timeline for quoting on your formula.
20) How do you determine the price for custom products?
Pricing is calculated based on the current landed cost of each material. Given the dynamic nature of the industry, component pricing can fluctuate rapidly. Accordingly, quotations are valid for 30 days and must be re-quoted if an order is not placed during that timeframe. We recommend that you approve your quotation and place your order immediately after approving the quotation as this will secure your price for that production run and will be most efficient for all parties.
21) Do you provide fulfillment services or will you warehouse my finished goods inventory?
No, we do not offer fulfillment services. We have close relationships with several fulfillment locations that have clients in the nutraceutical industry, to which we can refer you.
We manufacture to the quantity of your purchase order. We do not store excess finished goods for our customers.
22) Do you provide Certificates of Analysis?
Yes. Certificates of Analysis are provided according to the parameters defined in the Finished Product Specification.
23) Do you do in-house testing?
We conduct in-house organoleptic (color and smell) testing of all raw materials as well as testing specific to the manufacturing process such as weight checks, disintegration, hardness and friability. All other testing including microbial, heavy metals analysis and chemical analysis (identification and potency assay), as well as testing for solvent and pesticide residues is conducted by 3rd party government certified laboratories. Any additional testing requirements can be discussed with your Account Executive in conjunction with our Operations team.
24) What documents do you provide for finished products?
We provide a Certificate of Analysis, Commercial Invoice and a Packing Slip. If you require any additional documentation, these requirements must be identified on the sales order.
25) Who arranges and pays for shipping?
You do. You are responsible for freight costs and freight insurance. When you place your purchase order you will be asked to specify a shipping method and freight carrier, and to provide any special instructions. When your product is ready, our Sales Administrator will contact you and provide a packing slip. If you are shipping internationally (including to the United States), discuss all requirements with your customs broker or freight forwarder well in advance.
26) Can you manufacture effervescent powders and/or tablets?
We manufacture effervescent powders in bulk for outsourced filling in appropriate oxygen barrier packaging. We do not presently manufacture effervescent tablets.