Does Ideal Cures maintain Drug Master Files for their products?
Ideal Cures maintains US Type IV Drug Master Files for most of their products where applicable.
Are US Type IV Drug Master Files confidential?
US Type IV Drug Master Files are totally confidential and have no "open" part that can be reviewed by parties other than the FDA.
Is a Certificate of Suitability (CEP) available for Instacoat- Dry dispersion products?
A Certificate of Suitability (CEP) is only available for materials that are covered by a monograph on the current European Pharmacopoeia. Therefore a CEP is not applicable for Ideal Cures products.
Are Ideal Cures products Halal certified?
Ideal Cures products are not Halal certified at this time. However if required, steps will be taken to obtain Halal Certificate.
Are Ideal Cures products Kosher certified?
Some Ideal Cures products may be certified Kosher when produced at Ideal Cures sites evaluated by a Rabbinical Service.
Are letters of reference specific to a particular drug application or submission?
Letters of reference are not specific to a particular drug application and can be used for any submission that uses the product.
Do DMF letters of reference expire?
Letters of reference do not expire and updating them is not necessary.
What information is required for a DMF reference letter?
In order to issue DMF reference letters, Ideal Cures requires the customer's name, address, phone number, fax number, contact person and Ideal Cures Product formula number(s).
Does Ideal Cures provide letters of reference to their drug master files?
DMF reference letters may be requested by contacting our Regulatory Affairs department via the website or by email, phone or fax.
Are Ideal Cures products irradiated?
Ideal Cures products themselves are not subject to irradiation.
Is latex used in the manufacture of any Ideal Cures products?
Latex is not used in the manufacture of any Ideal Cures products. Additionally, Ideal Cures products do not come into contact with latex during manufacture or packaging.
Are Ideal Cures Products certified by TGA?
Few of the Ideal Cures products are already certified & available in the TGA notifications. The product details holding a ARTG No. can be provided on specific request.
Do Ideal Cures products contain any materials considered allergens?
Ideal Cures product has been evaluated for the source of the raw materials used in its production. There are no raw materials, including additives, used that have origin in peanuts, soybeans, milk, eggs, fish, shellfish, tree nuts and/or wheat or gluten. Based on this examination of the ingredients and their sources, Ideal Cures products are free of the specified known allergy stimulating food substances. Statements can be provided on specific requests.