1.What is Vitamin D3?
Definition:
Vitamin D is found in two forms: Vitamin D2 (ergocalciferol), a plant form produced by UV radiations of some yeasts, and Vitamin D3 (cholecalciferol), which is produced naturally by the body after sun exposure.
Vitamin D3, cholecalciferol, is a fat-soluble vitamin that aids the body's absorption of calcium and phosphorus; both of which are vital for strong bones. It got its name because it was discovered shortly after vitamins A, B, and C.
Vitamin D3, also known as the sunshine vitamin, is naturally synthesized by the body from absorbed ultraviolet rays following direct sunlight exposure, making it more of a hormone than a vitamin because it is produced endogenously by a human.
Cholecalciferol is the raw of vitamin D and, it is used to treat various medical conditions such as bone disorders (such as rickets and osteomalacia), hypoparathyroidism, and familial hypophosphatemia.
In addition, cholecalciferol is used as a nutritional supplement to maintain adequate vitamin D levels in the body or to treat vitamin D deficiency, as well as a variety of medical conditions related to vitamin D deficiency, such as osteoporosis and chronic kidney disease.
Breast-fed infants are also given cholecalciferol oral drops because breast milk often contains low levels of vitamin D.
Cholecalciferol can be obtained through adequate sun exposure or FDA-approved nutritional supplements and food, including milk, mushrooms, cod liver oil, and egg yolk.
Cholecalciferol is available in various forms, including chewable tablets, capsules, effervescent granules, ointment, cream, syrup, injection solutions, liquid solutions, and oral drops.
The Recommended Dietary Allowance (RDA) for the average daily level of cholecalciferol required for infants under one year is 400 to 1000 International Units (IU), 600 to 1000 IU for children and adolescents aged 1 to 18, and 1500 to 2000 IU for adults.
Chemical & Physical properties
Chemical structure:
Synonyms: Cholecalciferol, Calciol
Molecular formula: C27H44O
Molecular weight: 384.6
Melting point: 84-85 °C
CAS number: 67-97-0
DrugBank accession number: DB00169
IUPAC name: (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol
Color: a cream-colored powder.
Water solubility: Insoluble
Stability/Shelf Life: Within a few days, moist air oxidizes and deactivates it.
Brand names:
Adrovance®, Fosavance®, Pregvit®
2.Mechanism of action
After metabolizing both vitamins, vitamin D3 (cholecalciferol), and the plant-derived form, vitamin D2 (ergocalciferol) are converted in the liver by the enzyme cholecalciferol 25-hydroxylase into 25-hydroxycholecalciferol (calcifediol), which is then hydroxylated in the kidneys to produce 1,25-dihydroxycalciferol, also known as calcitriol.
Calcitriol is the active form of cholecalciferol that enters the blood and binds to Vit D binding protein (DBP) to exert the classical Vit D functions.
3. Forms and specifications
API Manufacturer: Fermenta Biotech Limited
Categories: Active Pharmaceutical Ingredients (API), Other APIs
Application: Pharmaceuticals, human dietary and nutritional supplements, human fortified food, animal feed supplements.
Shelf life: 24-36 months from the date of manufacturing.
Fermenta Biotech Limited is based in Thane, India, and is a leading manufacturer and global supplier of cholecalciferol. Fermenta Biotech Limited is one of the top three vitamin D3 manufacturers in the world.
Fermenta Biotech Limited offers diverse Vitamin D3 products, including Vitamin D3 500 feed grade powder (500,000 IU).
Vitamin D3 (cholecalciferol) from Fermenta Biotech Limited is available in a dosage of 40 MIU/g and is used in the pharmaceutical and human food industry. Additionally, Fermenta Biotech Limited offers cholecalciferol solutions with concentrations of 1, 2, and 4 MIU/g for use in the food industry and nutritional industry.
For animal nutritional products, cholecalciferol from Fermenta Biotech Limited is available as 40 MIU/g and used in the animal feed industry and feed supplement.
Cholecalciferol tablets are human nutritional supplements used by people who do not get enough vitamin D in their food to stay in good health.
Cholecalciferol tablets are also indicated in the treatment for various medical conditions, including osteoporosis, hyperparathyroidism, vitamin D-resistant rickets, and familial hypophosphatemia.
Cholecalciferol tablets are best taken after a meal, but they can be taken with or without food, and The chewable tablets must be chewed before swallowing.
Cholecalciferol food supplement is available as oil drop, which is effective and easily absorbed.
Cholecalciferol-oil drops are used to prevent and treat bone disorders caused by or related to vitamin D3 deficiency, such as rickets and osteomalacia.
The liquid doses should be measured carefully using the dropper which comes with the package.
The oil drops package should be shaken thoroughly before use, and it can be ingested directly or mixed with baby formula, fruit juice, or water.
It must be kept at room temperature, without freezing, and must be kept away from light.
4.Vitamin D vs Vitamin D3
The D vitamins are fat-soluble vitamins and hormone-like steroids, which are required for healthy bones and immune health and fertility.
Vitamin D, also known as calciferol, comes in two forms: cholecalciferol (it D3), which comes from animal sources and sun exposure, and ergocalciferol (it D2), which comes from plant sources and fortified foods.
5.Vitamin D2 vs Vitamin D3
The two vitamins differ depending on the food source. Cholecalciferol (Vit D3) is derived from animal sources (fish oil, liver, egg yolk, butter, etc.), whereas Ergocalciferol (Vit D2) is derived from plant sources (e.g., UV-grown mushrooms) and fortified foods.
Cholecalciferol (Vit D3) is produced naturally by the body after sun exposure from the compound 7-dehydrocholesterol in the skin.
Ergocalciferol (Vit D2) is synthesized from ergosterol, which is found in plant oils by ultraviolet radiations emitted by plants and mushrooms.
Because ergocalciferol (Vit D2) is the least expensive to produce, it is the most common in fortified foods, whereas cholecalciferol (Vit D3) boosts vitamin D levels.
An estimated half-hour of midday sun twice a week provides an adequate amount of vitamin D in Indian people, whereas in other countries, more time is required to achieve the same results.
6.Vitamin K2 vs Vitamin D3
Vitamins D and K capsules are both fat-soluble that play a pivotal role in the homeostasis of calcium for healthy bones.
Calcium is easily absorbed in the blood with cholecalciferol (Vit D3), and Vit K2 activates the protein osteocalcin, which integrates calcium into bone. Therefore, calcium cannot function properly in the absence of vitamins D3 and K2.
7.Vitamin D3 uses
Cholecalciferol for bones.
Cholecalciferol helps to strengthen muscles and bones, preventing weakness and brittleness, which can make bones vulnerable to diseases such as rickets in children, osteomalacia, and osteoporosis.
Cholecalciferol for immunity.
Cholecalciferol boosts immunity and aids in the prevention of infections such as respiratory infections and pneumonia.
Recent research has found that higher levels of cholecalciferol intake are linked to lower rates of COVID-19 infection and the severity of its complications.
Cholecalciferol for heart.
Several studies have shown that cholecalciferol treatment can significantly reverse the damage to the cardiovascular system caused by a variety of diseases, including high blood pressure, atherosclerosis, and diabetes mellitus.
8.Vitamin D3 side effects
The most common side effects of cholecalciferol include nausea, vomiting, constipation, headache, dry mouth, growth problems in children taking cholecalciferol, shortness of breath, and lethargy.
9.Vitamin D3 manufacturing process
The production of cholecalciferol begins with collecting wool from mature and live sheep to extract the cholesterol required for synthesis via solvent washes and/or column chromatography.
Cholesterol is then purified by chemical processes to produce 7-dehydrocholesterol, also known as ‘pre-Vit D3'.
Following that, the pre-Vit D3 is irradiated to produce Vit D3 (cholecalciferol); this is the same reaction used by human skin to produce vitamin D from the sun.
10.Vitamin D3 Market size and Trend
The Vitamin D Market was worth USD 0.9 billion in 2018 and is expected to grow at a CAGR of 6.2 percent from 2019 to 2026, reaching USD 1.6 billion.
Geographically, the global market includes the United States, Canada, Europe, Asia Pacific, China, Japan, and India.
According to the application, the global market includes animal feed & pet food, functional food & beverages, personal care, and pharmaceuticals.
11.Vitamin D3 API (Active Pharmaceutical Ingredient) bulk price
The average price is 189.8 (USD/Kgs).
12.Vitamin D3 Active Pharmaceutical Ingredients (APIs) manufacturers in china
Below are some professional pharma ingredients manufacturers in China.
Zhejiang Garden Biochemical High-tech Co., Ltd.
Zhejiang Garden Biochemical High-tech is a company that specializes in the production and sales of API all over the world.
Zhejiang Garden Biochemical High-tech company's commitment to providing high-quality nutritional products to improve the quality of human life and its focus on the value of innovating, creativity, and business responsibility, has earned her a respectable international reputation among global multi-national companies.
Business Type: Manufacturer, Supplier
Products: Vit D3 500 Feed Grade, Vit D3 Oil Food Grade, Vit D3 Crystal Pharma Grade, Dry Vit D3 Powder, and Vit D3 resin.
Price(USD): 0.00
Country: China
Main Sales Market: Western Europe, Australia, Asia, the Middle East, and Africa.
Zhejiang Weishi Biotechnology Co., Ltd.
The company has had a lot of success with the food industry, feed additives, and chemical raw materials development, production, sales, and marketing.
Vit D3 500 be used as feed additives in the feed industry. Mainly used in feed premix mixed with powders.
Business Type: Supplier, Distributor, Trading Company, Retailer, Service Provider, Manufacturer, Others.
Products: Vit D3 1MIU Oil, Vit D3 500CWD/CWS, Vit D3 100CWD/CWS, and Vit D3 500 SD.
Country: China
Main Sales Market: Western Europe, Australia, Asia, the Middle East, and Africa.
Taizhou Hisound Pharmaceutical Co., Ltd.
The Ministry of Agriculture of the People's Republic of China has given the company approval for feed-grade D3 beadlets, and the company's production technology for pharmaceutical grade Vitamin D3 is world-leading.
Business Type: Manufacturer, Supplier
Category: Active Pharmaceutical Ingredients
Products: Vit D3 Powder, Vit D3 Crystals, and Vit D3 Oil.
Country: China
Main Sales Market: Western Europe, Australia, Asia, the Middle East, and Africa.
Main Competitive Advantages: International Approvals/Standards, Experienced R&D Staff.
SICHUAN NEIJIANG HUIXIN PHARMACEUTICAL CO., Ltd.
Business Type: Manufacturer, Supplier, Trading Company
Category: Active Pharmaceutical Ingredient
Location: China
Xinfa Pharmaceutical Co., Limited.
The company is one of the global leading manufactures of animal feed additives, veterinary drug ingredients, complex pharmaceutical intermediates, and active pharmaceutical ingredients (API).
Business Type: Manufacturers, Suppliers
Location: China
Main sale Market: Western Europe, Australia, East Asia (e.g., China, Japan, Korea), South Asia (e.g., India), the Middle East, and Africa.
JIAXING MICROVIT BIOTECHNOLOGY CO., Ltd.
The company's focus on nutritional production, research, design, development, support, and services helped it become an industry leader.
Business Type: Manufacturers and Supplier of API
Grade: Animal feed grade, pharmaceutical grade, injection grade.
Location: China
VEGA PHARMA LIMITED (HANGZHOU VEGA CO., LTD).
Business Type: Trading Company, Supplier, Manufacturers
Price(USD):$30.00 - $60.00 / Kilogram
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References:
1. https://pubchem.ncbi.nlm.nih.gov/compound/Cholecalciferol
2. https://go.drugbank.com/drugs/DB00169
3. https://www.webmd.com/drugs/2/drug-10175/vitamin-d3-oral/details
4. https://www.ncbi.nlm.nih.gov/books/NBK441912/
5. https://www.ncbi.nlm.nih.gov/books/NBK532266/
6. https://www.fermentabiotech.com/vitamind3.php
7. https://www.rxlist.com/consumer_vitamin-d/drugs-condition.htm
8. https://www.drugs.com/cdi/cholecalciferol-drops.html
9. https://www.healthline.com/nutrition/vitamin-d2-vs-d3#TOC_TITLE_HDR_3
10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5613455/
11. https://pubmed.ncbi.nlm.nih.gov/33292313/
12. https://www.sciencedaily.com/releases/2018/01/180130140242.htm
13. https://vitamindwiki.com/Vitamin+D+manufacturing+details+-+2013
14. https://www.verifiedmarketresearch.com/product/vitamin-d-market/
15. https://www.pharmacompass.com/price/vitamind3-5280795
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Pharma Sources Insight JANUARY 2024
