Prothera Inc., dba SFI USA

ProThera Inc. dba SFI USA™ provides Custom Manufacturing to its customers if terms and conditions of Custom Manufacturing are met.  The terms and conditions include requirements for minimum order quantities, raw ingredients, customized label, and timelines.  (Refer to the below Terms and Conditions)

The Custom Manufacturing process is initiated, when a completed International Custom Manufacturing Request form is received by International Support USA (to request a form please contact SFI USA’s International Support Team at IntlUSA@sfihealth.com. SFI USA will verify and evaluate the request and prepare a Preliminary quote (Pre-Quote) which will include a Development Fee statement. For work to proceed, the customer must sign the Pre-Quote and return it with payment for the Development Fee (payment #1). 

SFI USA will then complete benchwork to test validity of the custom formula and send a final quote for the customer’s approval.  The customer must sign the Final Quote and return it along with payment of a deposit before SFI can proceed to manufacturing.  The deposit will be equivalent to 50% of the total quote.  Once the signed Final Quote and 50% deposit payment (payment #2) are received, SFI USA will manufacture the order within agreed timelines.  The completed order will be shipped once the final 50% payment (payment #3) has been confirmed.

The customer must ensure that Custom Manufacturing product(s) are legally compliant within the jurisdiction where they will be sold. Label claims must be appropriate to the product and written to comply with legal parameters of local market regulations. The customer assumes responsibility to undertake compliance activities, such as registration and/or notification, as required by local government and regulatory agencies. The customer is solely responsible for the fulfilment of any additional health, legal and administrative requirements concerning importation, storage, promotion, sales and distribution of the Custom Manufacturing products. Should the customer fail to act in accordance with this clause, the customer will be held liable for any loss or damage suffered or incurred by SFI USA.

The customer shall communicate all requirements for regulatory compliance at the beginning of the Custom Manufacturing process.  SFI USA shall evaluate the requirements and within reason make all basic scientific, analytical and technical documentation available to support the customer’s product compliance activities.

The customer will provide confirmation that custom formulated products are compliant within 14 days of receiving confirmation from the regulatory authority. Please refer to the International Private Label Policy and contact SFI USA’s International Support Team at IntlUSA@sfihealth.com.

The customer assumes all risks, costs and liabilities associated with clearing product(s) through local customs and border control. This includes all duties, fees, or other associated costs. The original product and shipping costs paid by the customer to SFI USA will not be credited or refunded if the product shipment fails to clear customs. Rules for importation vary by country. The customer should refer to import regulations for the relevant market. It is the customer’s responsibility to request from SFI USA the correct documentation necessary for customs clearance and notification/ registration prior to placing the order. The customer will therefore provide SFI with a valid list of export documents. Early discussion about which documents are needed is essential to the success of this process. (Refer to the International Shipping Policy for information about shipping the product/s.)

SFI USA makes no representations, warranties, or assurances as to the accuracy, currency, or completeness of the information provided. SFI USA shall not be liable for any damages or injury resulting from non-compliance to local market regulations.

TERMS AND CONDITIONS FOR INTERNATIONAL CUSTOM MANUFACTURINGS

1. Custom Manufacturing must be compliant to the intended local market regulations. This is a responsibility of the customer.
2. In compliance with US FDA current Good Manufacturing Practices (cGMP – 21 CFR Part 111), finished product testing must be performed on every production run.  The cost of the following tests will be included in your quotation:  Analytical potency, Microbiology, and Heavy Metals.
3. Additional testing may be requested and will be billed to the customer separately.  Additional testing requests are subject to SFI USA approval. Billing for the cost of additional testing may occur up to 24-months following completion of the testing.
4. Custom Manufacturing is subject to minimum order quantities (MOQ) which vary based on the specific nature of the formulation.  The MOQ is determined during the benchwork process and will be noted in the Pre-Quote.
5. Custom Manufacturing is restricted to 3 dosage forms: capsules, chewable tablets, powders.
6. Custom Manufacturing Pre-Quote and Final Quote are valid for 30 days from the date of the quotation letter.
7. Cancellations may incur a fee, depending on material costs.
8. Quotes do not include the cost of shipping the manufactured product.
9. Production yields may vary slightly from quoted quantities.
10. Expiry (Use by, Best By, Best Before) Dating for dietary supplements is optional in the US.  If the preference (or regulatory requirement) is to include an expiry date, additional testing for stability will be required and will impact the quotations.
11. Custom Manufacturing labels will be printed on coated label stock (in one or more colors) and applied by SFI USA.  The cost of standard labelling will be included in the quotations.  Customer-furnished labels or Customized Label design from SFI USA Graphics are subject to approval by SFI USA. Please refer to the  International Private Label Policy.