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Pure Finasteride Powder

1.Name:Finasteride/Proscar
2.Appearance:white powder
3.Specification:99%
4.CAS No.:98319-26-7
5.Molecular Formula:C23H36N2O2
6.Certificates: FDA,Organic,Kosher, ISO, HALAL, FSSC, cGMP
7.Transport Package:1kg Aluminum Foil Bag/25kg Drum
8.Factory situation:Factories & Three production lines.cGMP standard workshop & two independent laboratories.
9.Storage method:Dry and cool place
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  • Product Description

Pure Finasteride Powder: The Pharmaceutical Industry's Gold Standard for Hair Loss and Prostate Health Solutions

As one of Shaanxi Hongda's most advantageous products, pure finasteride powder is produced using our core "multi-stage dynamic recrystallization + nitrogen-protected ultrafine pulverization" technology, ensuring a purity consistently greater than 99.5% (USP/EP standard). Finasteride, as the gold standard for type II 5-reductase inhibitors, precisely blocks the conversion of testosterone to dihydrotestosterone (DHT). The key to choosing finasteride is not price, but rather "crystal purity" and "impurity profile control," which directly determine the onset of action and safety of the final product.

Shaanxi Hongda Phytochemistry Co., Ltd. is one of the world's leading companies. Utilizing decades of research and cutting-edge production technology, we produce pure finasteride that consistently exceeds industry demands. This is why pharmaceutical companies worldwide choose us first when they require reliable, high-quality active ingredients for formulation development.

finasteride powder

Advantages of Finasteride:

  • Extremely High Crystal Stability and Flowability:

Hongda controls the bulk density and flow index of the raw material through directional crystallization. Real-world testing data demonstrates that our powder exhibits excellent adaptability on high-speed tablet presses, significantly reducing rejection rates during production.

  • Stringent Control of Impurity A and Residual Solvents:

We perform ICP-MS and GC-MS combined analysis on process impurities and residual solvents in finasteride. This ensures that Impurity A levels are well below the pharmacopoeia limit, helping your brand easily pass FDA or EU EMA compliance audits.

  • Solubility Compatibility Support for Topical Hair Growth Liquids:

Hongda's technical team has developed an ultra-micro specification with a particle size controlled below 10 mmp, significantly improving its dissolution rate in ethanol, propylene glycol, and novel solvent systems, avoiding visible crystallization.

  • Strategic Spot Supply and Global Compliance Documentation:

We not only provide the raw material but also complete DMF (Technical Master File), CoA, and MSDS. We maintain a dynamic inventory of 5 tons of spot goods in our warehouses, and 10 tons each in our European and US warehouses, locking in competitive global pricing for the first quarter and promising 48-hour express shipping to ensure your supply chain remains rock-solid during peak demand season.


Product Specification

Item
Specification
Results
Appearance
White or off-white crystalline powder
Complies
Solubility
Freely soluble in methylene chloride and in alcohol; practically insoluble in water
Complie
a. IR-Spectrum
b. HPLC
Matches with working standard
Complies
Specific rotation
-56-- -60°
-58°
Water %
≤0.3
10.00%
Residue on ignition %
≤0.1
1.00%
Heavy metals ug/g
≤10
<10
Relative material %
Major ≤0.5
0.37
Total ≤1.0
0.56
Residual solvents%
Meets the requirements
Complies
Assay%
≥98.5
99.80%
Conclusion:Conform with enterprise specification

 

Pure Finasteride Powder Applications

How to Treat Androgenetic Alopecia (AGA) – Finasteride blocks Type-II 5-α reductase from functioning, which lowers DHT levels in the hair and blood by 60–70%. After using it every day for 12 to 24 months, 80% to 90% of male AGA patients see their hair follicles stop decreasing and start growing back.

Taking 5 mg of this medicine every day for benign prostatic hyperplasia (BPH) shrinks the prostate by around 25%, raises the peak urine flow rate by 1.5 to 2.0 mL s⁻², and cuts the risk of needing surgery or having acute urinary retention by more than 50%.

Topical and Compound Formulations—Pure powder is blended with minoxidil or liposomal bases (0.05–0.3% w/v) to form creams, foams, or microneedle patches for the scalp. Clinical investigations demonstrate that these products efficiently inhibit DHT on the scalp while significantly reducing systemic exposure.

Research and producing APIs: Powder that is 99.9% pure or above is employed as an analytical measure or as a pharmacologically active ingredient in tablets, capsules, films, and novel nano-carriers.

Finasteride benefits

Product Benefits

Flexible Dosing & Reduced Side-Effect Profile – When you put it on your skin as a cream, it doesn't get into your body as well as when you take it by mouth. This implies it works just as well and doesn't cause as many difficulties with sex, mood, or hormones.

Cost-Effective Bulk Supply – GMP-certified plants can provide APIs in amounts ranging from kilos to tons. Products that are reasonably priced make it possible to create finished medication forms for a cheap cost.

Broad Formulation Compatibility – DMSO, ethanol, and propylene glycol all dissolve Pure Finasteride Powder easily. Micronized grades (less than 10 µm) make the substance more even and enable topical treatments absorb into the skin.

 

Why Choose Our Manufacturing Partnership?

Regulatory Expertise: Our in-house regulatory team takes care of the complicated procedures for submitting to the FDA, EMA, and WHO. This makes it easy for your items to get to market.

Scalable Production: You can modify the size of the batch from 1 kg to 1,000 kg to meet your needs for time and output.

Cost Efficiency: Vertical integration lowers your costs by 15 to 20 percent, from managing the growth of raw materials to making the completed API.

Traceability: Pharmaceutical companies need to keep track of everything from when they get the raw materials to when the end product is issued.

Customization: Customized formulas, sterile processing, and custom packaging can help you make products that meet your specific demands.

 

Advanced Quality Control Process

The substances in your medicines should be of the highest quality. We make sure that the product is always safe and pure by using a thorough four-stage quality control process.

Stage 1: Raw material screening from our three proprietary cultivation bases under agronomist oversight
Stage 2: In-process testing using HPLC, GC, and heavy metal analysis
Stage 3: Comprehensive microbial and pesticide residue testing
Stage 4: Final product validation with traceable Certificate of Analysis

Every batch undergoes rigorous testing for heavy metals, microorganisms, and pesticide residues. Our SGS-standardized laboratories utilize cutting-edge equipment to guarantee pharmaceutical-grade quality.

Laboratory

Certifications & Global Compliance

We meet the strictest regulatory standards, backed by:

  • cGMP & ISO-Certified Facilities: Audited annually for quality consistency.
  • Third-Party Testing: Collaborations with SGS and Eurofins validate purity, heavy metals, and microbial limits.
  • DMF/CEP Readiness: Documentation support for FDA/EMA submissions.

Certifications


FAQ

1. How do you guarantee ≥99% purity?

Our SGS-standard labs use HPLC/GC-UV testing at multiple production stages.

2. Can you handle large orders?

Yes. With 3,000-ton annual capacity, we fulfill 500kg–5-ton requests without delays.

3. Is traceability documented?

Yes. Each batch has a COA detailing raw material origins and test results.

4. Do you offer sterile packaging?

Absolutely. Custom sterile options are available for injectable or oral formulations.

5. How do you ensure global compliance?

Our in-house regulatory team tailors documentation for FDA, EMA, or WHO requirements.

 

Get Started

Ready to integrate a high‑quality API into your pipeline? Request a quote or a free sample today. Reach us at duke@hongdaherb.com and our technical team will respond within 24 hours. Partner with a trusted manufacturer and experience the confidence that comes from using a rigorously tested, globally compliant product—your Pure Finasteride Powder solution for successful drug development.

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