Nobody has filed these yet.
330 products to make under your own brand: 100 formulations from sites in Spain and Germany, 115 from France and 115 finished medicines from Spain. Not one of them holds a file with the Iraqi MoH or the KMCA. Among them are vegan multivitamin gummies, probiotic stick packs, gastro-resistant capsules, liposomal vitamins and minerals and collagen powders. Nobody has applied. That is the opening.
Under your brand: 100 formulations from Spain and Germany
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Why an open file is worth taking
Import rights follow whoever holds the file. On these 100 nobody holds anything, because neither site has been filed in Iraq or the Kurdistan region. The position goes to the first applicant, and the queue is empty.
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What you hold
You are the applicant of record, not us. Exclusivity follows the file, so it lasts as long as you keep renewing. Change a pack size or a label later and the same file is varied. Move the product to another site and the file is updated, not started again.
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What we do
We collect what the authority asks for. Certificate of Analysis, specifications and stability data, Free Sale Certificate, the site's GMP certificate and manufacturing licence, certificate of origin, Arabic artwork, samples where they are requested. Legalisation goes through the Chamber of Commerce and the Iraqi embassy. You submit as the applicant, and we answer the queries with you.
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Two authorities, two files
The Kurdistan Medicine Control Agency runs its own review and issues its own certificate. A file in Baghdad does not cover the Kurdistan region, and the reverse holds too. In the catalogue 213 formulations come from sites filed with the Iraqi MoH only, 180 from sites filed with the KMCA only and 360 from sites filed with both. We prepare the two files separately, and you submit each as the applicant, so one market never waits for the other.
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Where the products are made
Both sites work to EU cGMP. The Spanish one carries 56 of the 100, the German one the other 44.
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How to start
Send the list and the market: Baghdad, the Kurdistan region or both. The answer comes back in writing. Minimums start at 5,000 units on the German gummy lines and 10,000 on the Spanish range. The production time, from formula lock and artwork approval, is set in our offer for each product, and the file is assembled while the line runs.
Review time belongs to the authority, not to us. It moves with the category, the queue and how complete the file is. We state the current expectation when you ask. We never give a date.
Under your brand: 115 formulations from France
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What the range holds
19 vitamins and minerals in liposomal form, among them vitamin C, D3 with K2, B12, iron, zinc, magnesium and glutathione. 12 liposomal blends of several actives. And 84 formulations in twelve groups: bones and joints, veins and circulation, nerves and sleep, immunity and the airways, digestion and probiotics, energy and performance, women's health, men's health, healthy ageing, skin, hair and nails, vegan nutrition, and collagen powders.
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Forms and packs
Most are capsules, in blisters of 15, 30 or 60 capsules and jars of 90 to 180. 12 are powders in pouches and tubs of 150 to 300 g, five of them collagens. Two softgels with fish oil, a herbal syrup, drinkable shots and a tablet complete the range. The liposomal vitamins and minerals come in vegetable capsule shells.
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No file in Iraq
No file for the French site is on record with the Iraqi MoH, and none is known at the KMCA. As with the formulations above, you become the applicant of record, and the exclusivity follows your file.
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How to start
Minimums start at 500 units per formula, so one first order can carry several formulas. Send your shortlist and the market: Baghdad, the Kurdistan region or both. The answer comes back in writing.