- Dosage: Biotin 100000iu
- Packaging: 120 capsules/bottle
- Shelf Life: 36months
Package:
Product Description
Biotin 100,000 IU Capsules: What the Published Guidance Says
Our largest functional group by product count — from the individual vitamins and minerals carried on the WHO Model List through to parenteral nutrition components and finished multivitamin presentations.
Biotin 100,000 IU Capsules is specified against its own monograph, pack size and market registration, so the guidance below is worth reading together with the Vitamins & Nutrition range overview.
- Anaemia prevention is a listed intervention Ferrous salt with folic acid appears on the Model List as an antianaemia medicine, in tablet form. Folic acid and iron are the standard pair used in national supplementation programmes, and matching your market's programme strength matters. WHO — Essential medicines (fact sheet)
- The Model List sections that carry this portfolio Vitamins and minerals sit in section 27 of the 24th WHO Model List (2025). The listings include ascorbic acid, cholecalciferol and ergocalciferol, iodine, nicotinamide, pyridoxine and retinol, alongside calcium and other minerals. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
- Presentation matters as much as molecule An essential medicine is meant to be provided in an appropriate dosage form for the intended use and patient. A clinic that stocks the right molecule in an inappropriate presentation has met availability and missed usability — which is why we supply chewables, effervescents, drops, syrups and injectables across the same active ingredients. WHO — Essential medicines (fact sheet)
These points are quoted because they shape how Biotin 100,000 IU Capsules is specified, labelled and purchased — including strength selection, pack size and the artwork wording. Confirm each one against the approved product information in your market before finalising a purchase order.
Biotin 100,000 IU Capsules — Supply Parameters
| Product Name | Biotin Capsules 100,000 IU (Vitamin B7 Oral Capsules) |
| Specification | Each capsule contains: Biotin (Vitamin B7) 100,000 IU (note: biotin is conventionally measured in micrograms (mcg); 100,000 IU corresponds to a high-strength biotin dose per labeling) |
| Dosage Form | Oral Hard Gelatin Capsule (for oral administration; swallow whole) |
| Active Ingredient | Biotin (Vitamin B7 / Vitamin H) |
| Pharmacological Class | Dietary Supplement (B-Complex Vitamin / Nutritional Support) |
| Route of Administration | Oral administration (swallow whole with water). May be taken with or without food. Typically taken once daily, as directed on the product label or by a healthcare professional. |
| Storage | Store below 25°C, in a dry place, protected from light and moisture. Keep container tightly closed. Do not freeze. |
| Therapeutic group | Vitamins & Nutrition — Vitamins & Nutrition |
| Manufacturer | Sinophare Bio-technology Co., Ltd. (GMP, China) |
| Documentation supplied | COA, HPLC/GC data, stability data, dossier package |
The same therapeutic range is supplied in several presentations, so one purchase order can cover a mixed requirement: Glutathione 500mg Capsules, Vitamin K2 180ug + D3 2400IU Soft Capsules, Collagen 1g Tablets, Creatine with Multivitamin & Mineral Granules, Fiveflavor Tablets Schisandra Berries P.E. Vitamin B1 B12, Ferrous Sulfate Tablets 50mg, Folic Acid Tablets 5mg, Multivitamin with Zinc Tablets.
Quality Control, Pharmacopoeial Standards & Documentation
Products are manufactured and tested against USP, EP, BP and CP monographs, with incoming raw-material inspection, in-process monitoring and full finished-product testing.
Biotin 100,000 IU Capsules is released against the pharmacopoeial monograph named on your order (USP, EP, BP or CP). Where no monograph exists for the exact presentation, the specification is agreed with you in writing before manufacture and is attached to the certificate of analysis.
Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.
A typical release panel for this presentation covers:
- Testing for description and identification
- Testing for assay of the active substance
- Testing for related substances and impurities
- Testing for dissolution or release profile (solid oral forms)
- Testing for uniformity of dosage units
- Testing for water content and pH where applicable
COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.
Packaging, Labelling & Export
- Pack size: Blister pack (PVC-Alu) or HDPE bottle, typically 30, 60, or 100 capsules per blister pack or bottle. Non-standard pack sizes can be quoted against your artwork.
- Storage: Store below 25°C, in a dry place, protected from light and moisture. Keep container tightly closed. Do not freeze..
- Shelf life: 36 months (unopened). Stability data for the marketed pack is included in the dossier.
- Labelling: artwork can be produced in English, Arabic, French, Russian and Spanish, with your own brand and language mix, subject to the labelling rules of the destination market.
- Export: GMP certificate, COA, certificate of origin, packing list and, where required, the free-sale or marketing authorisation certificate from the country of manufacture.
Registration, Dossier & Tender Support
Sinophare Bio-technology Co., Ltd. holds DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. That registration identifies the legal manufacturer on the certificate of analysis, the GMP certificate and the documents filed with your national medicines authority.
- CTD dossier modules 1–5 in editable and PDF form, with the finished-product and API sections cross-referenced.
- Site Master File and GMP certificate for the manufacturing workshops.
- Method validation, stability protocol and the shelf-life justification for the marketed pack.
- Answers to authority questions during assessment, handled by the regulatory contact who prepared the file.
- Tender and framework documentation, including pre-qualification questionnaires and sample logistics.
This page describes Biotin 100,000 IU Capsules as a product of the vitamins, minerals and clinical nutrition products named in the WHO Model List family. A WHO or national listing is a supply-context fact, not an approval in your market; marketing authorisation remains specific to each country.
Frequently Asked Questions
What pack size is available for Biotin 100,000 IU Capsules?
The reference pack is Blister pack (PVC-Alu) or HDPE bottle, typically 30, 60, or 100 capsules per blister pack or bottle. Non-standard blister, bottle and carton configurations are quoted against your artwork, matched to the stability data already held for the presentation.
What documentation comes with a shipment of Biotin 100,000 IU Capsules?
Each batch ships with a certificate of analysis covering description, identification, assay and related substances, plus stability data for the marketed pack and the GMP certificate of the manufacturing site. Shelf life: 36 months.
Does the batch documentation for Biotin 100,000 IU Capsules support a registration filing?
Each batch ships with a certificate of analysis covering description, identification, assay and related substances, plus stability data for the marketed pack and the GMP certificate of the manufacturing site. Shelf life: 36 months. The full CTD dossier and the authority assessment file are supplied as part of a registration order; routine shipments carry the COA and stability data only.
Which vitamins and minerals are on the WHO Model List?
Section 27 of the Model List carries minerals and vitamins including ascorbic acid, cholecalciferol and ergocalciferol, iodine, nicotinamide, pyridoxine and retinol. Ferrous salt with folic acid is listed as an antianaemia medicine.
Do you supply ferrous salt with folic acid?
Yes, in tablet form and in the strengths used by national anaemia-supplementation programmes. Confirm your programme's declared strength before ordering.
Related Vitamins & Nutrition Products
- Glutathione 500mg Capsules — 500mg
- Vitamin K2 180ug + D3 2400IU Soft Capsules — 180mcg
- Collagen 1g Tablets — 1g
- Creatine with Multivitamin & Mineral Granules — 5g
- Fiveflavor Tablets Schisandra Berries P.E. Vitamin B1 B12
- Ferrous Sulfate Tablets 50mg — 50mg
Browse the full Vitamins & Nutrition range; all Capsules; the complete product catalogue.
Request a Quotation for Biotin 100,000 IU Capsules
Send the specification, pack size, quantity and destination market for Biotin 100,000 IU Capsules 000IU and we will confirm availability, lead time and documentation. Tender quantities and registration samples are handled on the same quotation.
Sources & Regulatory Notes
- WHO — Essential medicines (fact sheet)
- WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
Reference information only. The published guidance summarised on this page is quoted for professional and regulatory-context purposes and does not constitute medical advice, a prescribing recommendation or a promotion of any product for a particular indication. Prescribing decisions must follow the approved product information and national treatment guidelines in the market of use.
