Compliance with Regulations
Pharmaquinone® products are identical to already authorized under Regulation (EC) 258/97 novel foods and these authorizations are not data protected according to the requirements of Article 26 of Regulation (EU) 2015/2283. Therefore Pharmaquinone® products have been placed in the EU market without a dedicated application. The specifications and conditions of use of Pharmaquinone® products are in line with the authorized specifications and conditions of use as set out in the Union list of authorized novel foods and/or the implementing Regulations authorizing these substancesin accordance with Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods.
Stability program follows ICH Guideline to meet market specific requirements.
To the best of our knowledge, the product Pharmaquinone®, Vitamin K2 as MK-7 does not infringe any patent rights, rights in inventions, copyright and related rights in information (including protected know-how, confidentiality and trade secrets) (“IPRs”), belonging to a third party based on the comprehensive overview of the patents‘ situation (granted and pending) in Europe.
Pharmaquinone® Product, Vitamin K2 as MK-7 is a generic of the well-established and safe for human consumption original active ingredient, which has achieved GRAS in USA and novel food status in EU. The product is intended for use in the manufacturing of food products, including food supplements. Our process ensures the best quality and accordance to European novel food specification, being accepted by the Health Authorities as a reference for the manufacturers.
* 100% MCT Oil coconut based, organic
** The actual values may vary slightly due to the applied technological overage of MK-7.
Free from allergens in compliance with EU Directive 1169/2011 Annex II
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
36 months from manufacture. The product should be stored at temperature 15-25°C / 59-77°F, in a dry place. Partial crystallization may occur at lower temperature. Protect from light.
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
Compliance with Regulations
Pharmaquinone® products are identical to already authorized under Regulation (EC) 258/97 novel foods and these authorizations are not data protected according to the requirements of Article 26 of Regulation (EU) 2015/2283. Therefore Pharmaquinone® products have been placed in the EU market without a dedicated application. The specifications and conditions of use of Pharmaquinone® products are in line with the authorized specifications and conditions of use as set out in the Union list of authorized novel foods and/or the implementing Regulations authorizing these substancesin accordance with Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods.
Stability program follows ICH Guideline to meet market specific requirements.
To the best of our knowledge, the product Pharmaquinone®, Vitamin K2 as MK-7 does not infringe anypatent rights, rights in inventions, copyright and related rights in information (including protected know-how, confidentiality and trade secrets) (“IPRs”), belonging to a third party based on the comprehensive overview of the patents‘ situation (granted and pending) in Europe.
Pharmaquinone® Product, Vitamin K2 as MK-7 is a generic of the well-established and safe for human consumption original active ingredient, which has achieved GRAS in USA and novel food status in EU. The product is intended for use in the manufacturing of food products, including food supplements. Our process ensures the best quality and accordance to European novel food specification, being accepted by the Health Authorities as a reference for the manufacturers.
* 100% MCT Oil coconut based, organic
** The actual values may vary slightly due to the applied technological overage of MK-7.
Free from allergens in compliance with EU Directive 1169/2011 Annex II
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
36 months from manufacture. The product should be stored at temperature 15-25°C / 59-77°F, in a dry place. Partial crystallization may occur at lower temperature. Protect from light.
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
Compliance with Regulations
Pharmaquinone® products are identical to already authorized under Regulation (EC) 258/97 novel foods and these authorizations are not data protected according to the requirements of Article 26 of Regulation (EU) 2015/2283. Therefore Pharmaquinone® products have been placed in the EU market without a dedicated application. The specifications and conditions of use of Pharmaquinone® products are in line with the authorized specifications and conditions of use as set out in the Union list of authorized novel foods and/or the implementing Regulations authorizing these substancesin accordance with Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods.
Stability program follows ICH Guideline to meet market specific requirements.
To the best of our knowledge, the product Pharmaquinone®, Vitamin K2 as MK-7 does not infringe anypatent rights, rights in inventions, copyright and related rights in information (including protected know-how, confidentiality and trade secrets) (“IPRs”), belonging to a third party based on the comprehensive overview of the patents‘ situation (granted and pending) in Europe.
Pharmaquinone® Product, Vitamin K2 as MK-7 is a generic of the well-established and safe for human consumption original active ingredient, which has achieved GRAS in USA and novel food status in EU. The product is intended for use in the manufacturing of food products, including food supplements. Our process ensures the best quality and accordance to European novel food specification, being accepted by the Health Authorities as a reference for the manufacturers.
** The actual values may vary slightly due to the applied technological overage of MK-7.
Free from allergens in compliance with EU Directive 1169/2011 Annex II
* in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
18 months from manufacture. The product should be stored at temperature 15-25°C / 59-77°F, in a dry place. Protect from light.
* in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
Compliance with Regulations
Pharmaquinone® products are identical to already authorized under Regulation (EC) 258/97 novel foods and these authorizations are not data protected according to the requirements of Article 26 of Regulation (EU) 2015/2283. Therefore Pharmaquinone® products have been placed in the EU market without a dedicated application. The specifications and conditions of use of Pharmaquinone® products are in line with the authorized specifications and conditions of use as set out in the Union list of authorized novel foods and/or the implementing Regulations authorizing these substancesin accordance with Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods.
Stability program follows ICH Guideline to meet market specific requirements.
To the best of our knowledge, the product Pharmaquinone®, Vitamin K2 as MK-7 does not infringe anypatent rights, rights in inventions, copyright and related rights in information (including protected know-how, confidentiality and trade secrets) (“IPRs”), belonging to a third party based on the comprehensive overview of the patents‘ situation (granted and pending) in Europe.
Pharmaquinone® Product, Vitamin K2 as MK-7 is a generic of the well-established and safe for human consumption original active ingredient, which has achieved GRAS in USA and novel food status in EU. The product is intended for use in the manufacturing of food products, including food supplements. Our process ensures the best quality and accordance to European novel food specification, being accepted by the Health Authorities as a reference for the manufacturers.
* 100% MCT Oil coconut based, organic
** The actual values may vary slightly due to the applied technological overage of MK-7.
Free from allergens in compliance with EU Directive 1169/2011 Annex II
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
36 months from manufacture. The product should be stored at temperature 15-25°C / 59-77°F, in a dry place. Partial crystallization may occur at lower temperature. Protect from light.
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
Compliance with Regulations
Pharmaquinone® products are identical to already authorized under Regulation (EC) 258/97 novel foods and these authorizations are not data protected according to the requirements of Article 26 of Regulation (EU) 2015/2283. Therefore Pharmaquinone® products have been placed in the EU market without a dedicated application. The specifications and conditions of use of Pharmaquinone® products are in line with the authorized specifications and conditions of use as set out in the Union list of authorized novel foods and/or the implementing Regulations authorizing these substancesin accordance with Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods.
Stability program follows ICH Guideline to meet market specific requirements.
To the best of our knowledge, the product Pharmaquinone®, Vitamin K2 as MK-7 does not infringe any patent rights, rights in inventions, copyright and related rights in information (including protected know-how, confidentiality and trade secrets) (“IPRs”), belonging to a third party based on the comprehensive overview of the patents‘ situation (granted and pending) in Europe.
Pharmaquinone® Product, Vitamin K2 as MK-7 is a generic of the well-established and safe for human consumption original active ingredient, which has achieved GRAS in USA and novel food status in EU. The product is intended for use in the manufacturing of food products, including food supplements. Our process ensures the best quality and accordance to European novel food specification, being accepted by the Health Authorities as a reference for the manufacturers.
* The actual values may vary slightly due to the applied technological overage of MK-7.
Free from allergens in compliance with EU Directive 1169/2011 Annex II
1 namely: wheat, rye, barley, oats, spelt, kamut or their hybridized strains.
2 namely: almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoinensis(Wangenh.) K. Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia or Queensland nuts (Macadamia ternifolia)
3 at concentrations of more than 10 mg/kg or 10 mg/litre in terms of the total SO2 which are to be calculated for products as proposed ready for consumption or asreconstituted according to the instructions of the manufacturers
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
36 months from manufacture. The product should be stored at temperature 15-25°C / 59-77° F, in a dryplace. Protect from light.
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
Compliance with Regulations
Pharmaquinone® products are identical to already authorized under Regulation (EC) 258/97 novel foods and these authorizations are not data protected according to the requirements of Article 26 of Regulation (EU) 2015/2283. Therefore Pharmaquinone® products have been placed in the EU market without a dedicated application. The specifications and conditions of use of Pharmaquinone® products are in line with the authorized specifications and conditions of use as set out in the Union list of authorized novel foods and/or the implementing Regulations authorizing these substancesin accordance with Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods.
Stability program follows ICH Guideline to meet market specific requirements.
To the best of our knowledge, the product Pharmaquinone®, Vitamin K2 as MK-7 does not infringe any patent rights, rights in inventions, copyright and related rights in information (including protected know-how, confidentiality and trade secrets) (“IPRs”), belonging to a third party based on the comprehensive overview of the patents‘ situation (granted and pending) in Europe.
Pharmaquinone® Product, Vitamin K2 as MK-7 is a generic of the well-established and safe for human consumption original active ingredient, which has achieved GRAS in USA and novel food status in EU. The product is intended for use in the manufacturing of food products, including food supplements. Our process ensures the best quality and accordance to European novel food specification, being accepted by the Health Authorities as a reference for the manufacturers.
* The actual values may vary slightly due to the applied technological overage of MK-7.
Free from allergens in compliance with EU Directive 1169/2011 Annex II
1 namely: wheat, rye, barley, oats, spelt, kamut or their hybridized strains.
2 namely: almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoinensis(Wangenh.) K. Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia or Queensland nuts (Macadamia ternifolia)
3 at concentrations of more than 10 mg/kg or 10 mg/litre in terms of the total SO2 which are to be calculated for products as proposed ready for consumption or asreconstituted according to the instructions of the manufacturers
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
36 months from manufacture. The product should be stored at temperature 15-25°C / 59-77° F, in a dryplace. Protect from light.
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
Compliance with Regulations
Pharmaquinone® products are identical to already authorized under Regulation (EC) 258/97 novel foods and these authorizations are not data protected according to the requirements of Article 26 of Regulation (EU) 2015/2283. Therefore Pharmaquinone® products have been placed in the EU market without a dedicated application. The specifications and conditions of use of Pharmaquinone® products are in line with the authorized specifications and conditions of use as set out in the Union list of authorized novel foods and/or the implementing Regulations authorizing these substancesin accordance with Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods.
To the best of our knowledge, the product Pharmaquinone®, Vitamin K2 as MK-7 does not infringe any patent rights, rights in inventions, copyright and related rights in information (including protected know-how, confidentiality and trade secrets) (“IPRs”), belonging to a third party based on the comprehensive overview of the patents‘ situation (granted and pending) in Europe.
Pharmaquinone® Product, Vitamin K2 as MK-7 is a generic of the well-established and safe for human consumption original active ingredient, which has achieved GRAS in USA and novel food status in EU. The product is intended for use in the manufacturing of food products, including food supplements. Our process ensures the best quality and accordance to European novel food specification, being accepted by the Health Authorities as a reference for the manufacturers.
* The actual values may vary slightly due to the applied technological overage of MK-7.
Free from allergens in compliance with EU Directive 1169/2011 Annex II
1 namely: wheat, rye, barley, oats, spelt, kamut or their hybridized strains.
2 namely: almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoinensis(Wangenh.) K. Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia or Queensland nuts (Macadamia ternifolia)
3 at concentrations of more than 10 mg/kg or 10 mg/litre in terms of the total SO2 which are to be calculated for products as proposed ready for consumption or asreconstituted according to the instructions of the manufacturers
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
36 months from manufacture. The product should be stored at temperature 15-25°C / 59-77° F, in a dryplace. Protect from light.
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
Compliance with Regulations
Pharmaquinone® products are identical to already authorized under Regulation (EC) 258/97 novel foods and these authorizations are not data protected according to the requirements of Article 26 of Regulation (EU) 2015/2283. Therefore Pharmaquinone® products have been placed in the EU market without a dedicated application. The specifications and conditions of use of Pharmaquinone® products are in line with the authorized specifications and conditions of use as set out in the Union list of authorized novel foods and/or the implementing Regulations authorizing these substancesin accordance with Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods.
Stability program follows ICH Guideline to meet market specific requirements.
To the best of our knowledge, the product Pharmaquinone®, Vitamin K2 as MK-7 does not infringe any patent rights, rights in inventions, copyright and related rights in information (including protected know-how, confidentiality and trade secrets) (“IPRs”), belonging to a third party based on the comprehensive overview of the patents‘ situation (granted and pending) in Europe.
Pharmaquinone® Product, Vitamin K2 as MK-7 is a generic of the well-established and safe for human consumption original active ingredient, which has achieved GRAS in USA and novel food status in EU. The product is intended for use in the manufacturing of food products, including food supplements. Our process ensures the best quality and accordance to European novel food specification, being accepted by the Health Authorities as a reference for the manufacturers.
* The actual values may vary slightly due to the applied technological overage of MK-7.
Free from allergens in compliance with EU Directive 1169/2011 Annex II
1 namely: wheat, rye, barley, oats, spelt, kamut or their hybridized strains.
2 namely: almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoinensis(Wangenh.) K. Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia or Queensland nuts (Macadamia ternifolia)
3 at concentrations of more than 10 mg/kg or 10 mg/litre in terms of the total SO2 which are to be calculated for products as proposed ready for consumption or asreconstituted according to the instructions of the manufacturers
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
36 months from manufacture. The product should be stored at temperature 15-25°C / 59-77° F, in a dryplace. Protect from light.
* in-house method
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** bile tolerant gram-negative bacteria include Enterobacteriaceae, Pseudomonas and Aeromonas
Compliance with Regulations
Pharmaquinone® products are identical to already authorized under Regulation (EC) 258/97 novel foods and these authorizations are not data protected according to the requirements of Article 26 of Regulation (EU) 2015/2283. Therefore Pharmaquinone® products have been placed in the EU market without a dedicated application. The specifications and conditions of use of Pharmaquinone® products are in line with the authorized specifications and conditions of use as set out in the Union list of authorized novel foods and/or the implementing Regulations authorizing these substancesin accordance with Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods.
Stability program follows ICH Guideline to meet market specific requirements.
To the best of our knowledge, the product Pharmaquinone®, Vitamin K2 as MK-7 does not infringe any patent rights, rights in inventions, copyright and related rights in information (including protected know-how, confidentiality and trade secrets) (“IPRs”), belonging to a third party based on the comprehensive overview of the patents‘ situation (granted and pending) in Europe.
Pharmaquinone® Product, Vitamin K2 as MK-7 is a generic of the well-established and safe for human consumption original active ingredient, which has achieved GRAS in USA and novel food status in EU. The product is intended for use in the manufacturing of food products, including food supplements. Our process ensures the best quality and accordance to European novel food specification, being accepted by the Health Authorities as a reference for the manufacturers.
Free from allergens in compliance with EU Directive 1169/2011 Annex II
* in-house UPLC method based on J. Pharm, Biomed. Anal. 135, 116-125
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** in-house method
**** in-house method, validated according to ICH Guideline Q3C(9R) and Q2(R2)
36 months from manufacture. The product should be stored at temperature 15-25°C / 59-77°F, in a dry place. Partial crystallization may occur at lower temperature. Protect from light.
* in-house UPLC method based on J. Pharm, Biomed. Anal. 135, 116-125
** in accordance with Dietary Supplement Monograph, Menaquinone-7 Preparation, USP-NF
*** in-house method
**** in-house method, validated according to ICH Guideline Q3C(9R) and Q2(R2)
