Share This Page
Suppliers and packagers for generic pharmaceutical drug: FOLIC ACID
✉ Email this page to a colleague
FOLIC ACID
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | FOLIC ACID | folic acid | INJECTABLE;INJECTION | 089202 | ANDA | Fresenius Kabi USA, LLC | 63323-184-10 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-184-10) / 10 mL in 1 VIAL, MULTI-DOSE | 2000-09-05 |
| Xgen Pharms | FOLIC ACID | folic acid | INJECTABLE;INJECTION | 202522 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-1100-1 | 1 VIAL, MULTI-DOSE in 1 CARTON (39822-1100-1) / 10 mL in 1 VIAL, MULTI-DOSE | 2019-11-17 |
| Solubiomix | QUIOFIC | folic acid | SOLUTION;ORAL | 216395 | NDA | Solubiomix, LLC | 69499-501-75 | 75 mL in 1 BOTTLE (69499-501-75) | 2026-01-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Folic Acid (API and Excipients)
Who supplies folic acid as an active pharmaceutical ingredient (API)?
Folic acid is a commoditized bulk API used across supplements and multiple therapeutic areas. In practice, the supplier landscape splits into (1) certified chemical manufacturers selling folic acid API to pharma/health firms and (2) ingredient distributors and contract-manufacturing channels that source from those chemical manufacturers.
Core manufacturer categories and common supply routes
| Supply route | Typical buyer | What the buyer receives | Typical documentation |
|---|---|---|---|
| API manufacturer (chemical producer) | Pharma, supplement makers | Folic acid API (typically powder grades) | COA, typical GMP package depending on facility |
| Ingredient distributors | Finished-dose manufacturers | API sourced from multiple plants | Distributor COA plus manufacturer CoA on request |
| Toll/contract manufacturing | Brand owners | Folic acid integrated into premix/blends or finished formulations | GMP batch records for the dosage form; API COA package |
Major global API manufacturers and long-established producers (representative)
The market includes both legacy chemical producers and large chemical groups with pharma-grade product lines. Commonly encountered brands in tenders and industry sourcing include:
- Hangzhou Dayangchem Co., Ltd. (China)
- Shanghai Macklin Biochemical Co., Ltd. (China)
- BASF (via its heritage chemical/pharma supply chain in vitamins) (Germany-based group; sourcing varies by region)
- DSM-Firmenich legacy vitamin supply footprint (Netherlands-based; product availability varies by contract and region)
- Merck (MilliporeSigma; grades for research and some commercial channels) (US/Germany group; channel depends on intended use)
These entities appear in procurement catalogs, MSDS/COA listings, or distributor offerings for folic acid. For pharma use, buyers typically qualify suppliers via quality agreements, audits, and documentation review.
Key procurement reality: many finished-dose manufacturers purchase folic acid through ingredient distributors, even when the underlying manufacturing is done by a bulk API chemical producer. The quality package and audit trail matter more than brand name.
Who supplies folic acid for dietary supplements and tablet/capsule formulations?
Supplement supply chains usually buy one of two inputs: folic acid API or folic acid premixes. The downstream list is dominated by ingredient distributors, formulation vendors, and bulk vitamin ingredient companies.
Common supplier roles in supplement sourcing
| Supplier type | Where they show up | Typical SKU | Typical use |
|---|---|---|---|
| Vitamin ingredient distributors | Regional procurement | Bulk folic acid API | Formulation, blending |
| Co-packers and contract formulators | Brand packaging | Premix or finished tablets | Supplements under brand |
| Bulk nutraceutical ingredient brands | Global retailers | Folic acid ingredient lines | Supplement products |
In these channels, “supplier” often means the distributor or the co-packer rather than the original chemical producer.
Which regions dominate folic acid supply?
Geographic pattern
Folic acid is produced at scale in China and India, with additional supply coming from Europe and the US through specialty chemical and vitamin ingredient companies and distributors. In most procurement programs, bids typically come from:
- China-headquartered chemical producers
- India-headquartered vitamin/chemical manufacturers
- European and US distributors who aggregate supply and provide compliance paperwork
This distribution pattern persists because folic acid is weight-dominant and commodity-priced, making logistics and documentation efficiency key.
What quality and compliance documents buyers usually require?
Because folic acid is used in both pharma and supplements, documentation expectations differ by application. For pharma-grade use, suppliers are typically expected to provide a complete quality package.
Standard documentation package
| Document | Purpose | Common requirement |
|---|---|---|
| Certificate of Analysis (COA) | Batch-specific quality | Lot-specific release data |
| Specification sheet | Confirm tested attributes | Assay, impurity profile, appearance, moisture |
| MSDS/SDS | Safety documentation | Risk handling and transport |
| GMP statement (or equivalent) | Manufacturing system assurance | Facility statement for pharma-grade |
| Traceability info | Batch genealogy and chain of custody | Lot traceability and re-test policy |
Typical quality targets (what buyers check)
Sourcing teams generally evaluate:
- Assay / potency (folic acid content)
- Impurities (including related substances)
- Particle and bulk density (for blending performance in tablets/premixes)
- Solubility and stability behavior (for specific dosage form strategies)
- Microbial limits (especially for supplements and pharma blends, depending on risk classification)
How to segment suppliers for folic acid: API-grade vs excipient-grade
Folic acid is sometimes supplied as an ingredient for tablets (active) and sometimes treated like an ingredient grade for supplement formulations. The supplier universe and paperwork differ.
Supplier segmentation matrix
| Buyer goal | Best-fit supplier profile | Rationale |
|---|---|---|
| Pharma API registration or QC release | API manufacturer with GMP traceability | Higher audit and documentation readiness |
| Supplement formulation | Vitamin ingredient distributor or co-packer | Fast logistics and flexible lot sizes |
| High-volume commodity supply | Bulk API chemical producer | Lowest unit economics at scale |
| Specialty/regulatory-heavy programs | Qualified pharma-grade supplier | Documentation completeness and stable specs |
Where distributors fit: what buyers should expect in the commercial offer
Many commercial offers list folic acid under catalog numbers and provide a COA on request or standard COA at shipment. Distributor-led sourcing typically delivers:
- Short lead times via inventory
- Lot-level COAs that match customer orders
- Supplier-of-record disclosures that may require qualification if buyers need direct manufacturer oversight
For pharma programs, buyers often require:
- Audit or qualification package for the underlying manufacturer
- Confirmation that the delivered lot matches the specified grade/specification
What are the main procurement considerations that determine supplier suitability?
Pricing and supply risk
Folic acid is commodity-priced, so supplier selection often hinges on:
- Availability of stable supply from a qualified plant
- Consistency of impurity profile and potency across lots
- Ability to deliver required packaging format (drums, liners, moisture barriers)
Packaging and handling
Powder vitamins are sensitive to:
- Moisture uptake
- Segregation and caking behavior in bulk handling
- Cross-contamination risk in shared warehouses
Suppliers that provide robust packaging and clear handling instructions reduce downstream formulation failure risk.
Key Takeaways
- Folic acid sourcing is dominated by commodity bulk API producers in China and India, with Europe and the US supplying through distributors and vitamin ingredient channels.
- “Supplier” in commercial practice often means a distributor or co-packer, not the chemical producer, so the deciding factor is the quality package and the audit trail for the delivered lot.
- Buyer qualification typically centers on COA, specifications, GMP/manufacturing statements (as applicable), and impurity/potency consistency.
- Supplier shortlists should segment by API-grade for pharma use versus ingredient-grade for supplements, because documentation expectations differ.
FAQs
1) What is the most common source model for folic acid in supplements?
Ingredient distributors and co-packers typically supply folic acid API or premix blends sourced from bulk chemical producers, with batch COAs provided per lot.
2) Are the same suppliers used for folic acid API and dietary supplement markets?
Often yes at the chemical-manufacturer level, but the market-facing supplier role and documentation level differ by buyer and intended regulatory use.
3) What documents matter most when qualifying folic acid suppliers?
Lot COAs, detailed specifications (assay and impurities), and the manufacturing quality statement or GMP readiness package appropriate to the intended use.
4) Which regions usually win on supply continuity and volume for folic acid?
China and India typically dominate bulk availability, while Europe and the US often lead in distribution, packaging options, and compliance-facing support.
5) What tends to cause formulation delays when sourcing folic acid?
Lot-to-lot variability in potency/impurities, inadequate packaging for moisture control, or missing documentation for the intended regulatory pathway.
References (APA)
[1] Merck. (n.d.). Folic acid product information and safety documentation (selected catalog entries). Merck. https://www.sigmaaldrich.com/
[2] Hangzhou Dayangchem Co., Ltd. (n.d.). Folic acid product listing and documents (selected entries). https://www.dayangchem.com/
[3] Shanghai Macklin Biochemical Co., Ltd. (n.d.). Folic acid product listing and documents (selected entries). https://www.macklinchem.com/
More… ↓
