Suppliers and packagers for generic pharmaceutical drug: METHYLTESTOSTERONE

METHYLTESTOSTERONE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Impax Labs	METHYLTESTOSTERONE	methyltestosterone	TABLET;ORAL	080767	ANDA	Amneal Pharmaceuticals of New York LLC	0115-7037-01	100 TABLET in 1 BOTTLE (0115-7037-01)	1974-10-17
Novitium Pharma	METHYLTESTOSTERONE	methyltestosterone	CAPSULE;ORAL	215270	ANDA	Novitium Pharma LLC	70954-255-10	100 CAPSULE in 1 BOTTLE (70954-255-10)	2022-02-18

Methyltestosterone Suppliers: A Comprehensive Analysis of Global Pharmaceutical Supply Chains

Methyltestosterone, a synthetic androgen with applications ranging from hormone replacement therapy to palliative breast cancer treatment, occupies a critical niche in global pharmaceutical markets. The drug's supply chain reveals complex manufacturing networks, stringent regulatory environments, and evolving market dynamics. This report analyzes the key suppliers, pricing strategies, regulatory challenges, and emerging trends shaping Methyltestosterone production and distribution.

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Therapeutic Applications and Clinical Significance

Methyltestosterone primarily addresses testosterone deficiency in males, treating conditions such as delayed puberty, hypogonadism, and androgen insufficiency[6][11]. In females, it is prescribed for metastatic breast cancer, often in combination with estrogen therapy for menopausal symptom management[6]. Its mechanism of action mimics endogenous testosterone, binding to androgen receptors to regulate protein synthesis and cellular growth[6]. Despite its therapeutic benefits, the drug’s anabolic properties have led to regulatory scrutiny, particularly concerning off-label misuse in sports and bodybuilding.

The global demand for Methyltestosterone remains stable, driven by rising diagnoses of hormonal disorders and cancer[4]. However, supply chain complexities—including raw material sourcing, geopolitical trade policies, and manufacturing compliance—create bottlenecks that influence pricing and availability.

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Global Supplier Landscape

Asia-Pacific Dominance in Bulk Production

China and India collectively supply over 60% of Methyltestosterone APIs (Active Pharmaceutical Ingredients), leveraging cost-effective labor and scaled production facilities. Key players include:

• Zhuzhou New Peptides Tech Co., Ltd. (China): Offers 99.9% purity Methyltestosterone at $5/50g, targeting small-scale buyers[1].
• Samex Overseas (India): Provides GMP-certified APIs with 99% purity, emphasizing export-ready packaging and competitive pricing ($1,000–$2,500/kg)[11].
• Nuray Chemicals Private Limited (India): Specializes in high-volume orders (5–25 kg batches) for generic drug manufacturers[2][5].

These suppliers dominate the generic Methyltestosterone market but face challenges such as API price volatility and stringent import inspections in Western markets.

North American Regulatory-Compliant Manufacturers

U.S.-based suppliers focus on niche markets, including branded formulations and clinical-grade APIs:

• LGM Pharma (USA): Supplies FDA-approved Methyltestosterone for compounding pharmacies, with prices exceeding $5,800/100 capsules[8].
• American Custom Chemicals Corporation: Targets research institutions, offering 95% pure Penmestrol at $501.28/5mg[1].
• Steraloids Inc.: Provides high-purity Methyltestosterone for academic research, adhering to USP-NF standards[1].

While North American manufacturers account for <15% of global production, their products command premium pricing due to regulatory compliance and quality assurance.

European Suppliers and Distribution Networks

Europe’s Methyltestosterone market relies on a mix of regional manufacturers and distributors:

• ABCR GmbH & Co. KG (Germany): Supplies APIs to EU-based pharmacies, with strict adherence to EMA Good Distribution Practices[1].
• Axplora (Netherlands): Focuses on oncology-grade Methyltestosterone for breast cancer treatment, partnering with hospitals in France and Germany[3][5].
• Brunschwig Chemie: Distributes APIs to compounding facilities in Benelux countries, emphasizing cold-chain logistics[1].

Tariff adjustments post-Brexit and EMA’s centralized authorization process have intensified competition among European suppliers, particularly for bioequivalent generic formulations.

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Regulatory Compliance and Quality Assurance

Good Manufacturing Practices (GMP)

All major Methyltestosterone suppliers must comply with GMP guidelines to ensure product safety and efficacy. For example:

• AdvaCare Pharma maintains GMP certifications across facilities in China, India, and the U.S., with third-party audits validating their 99.9% purity claims[6].
• Symbiotec Pharmalab (India) holds a CEP (Certificate of Suitability) from the EDQM, enabling seamless API exports to EU markets[5].

Regulatory filings such as the U.S. Drug Master File (USDMF) and European WC (Written Confirmation) are critical for market access. Non-compliant suppliers—often smaller Chinese firms—face import bans, as seen in FDA’s 2024 sanctions against unregistered APIs[2][3].

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Pricing Dynamics and Market Segmentation

Cost Disparities Across Regions

Methyltestosterone pricing varies widely by region and distribution channel:	Region	Formulation	Price Range	Key Supplier
China	API (1 kg)	$1,000–$2,500	Zhuzhou New Peptides
India	API (1 kg)	$800–$1,800	Samex Overseas
USA	Oral Capsules	$5,800/100 caps	LGM Pharma
EU	Injectable (10mg)	€450–€600/vial	Axplora

Generic competition in Asia-Pacific drives down API prices, while U.S. brand-name formulations remain costly due to patent protections and distribution markups[8][4].

Distribution Channels

• Hospital Pharmacies: Dispense 70% of Methyltestosterone in clinical settings, particularly for HRT and cancer therapy[4].
• Retail Pharmacies: Dominated by oral tablets in emerging markets, with India’s retail sector growing at 8.2% CAGR[4].
• Online Pharmacies: Account for 12% of U.S. sales, driven by telemedicine platforms offering discreet delivery[8].

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Challenges in the Methyltestosterone Supply Chain

Raw Material Sourcing

Androstenedione, a key precursor for Methyltestosterone synthesis, faces supply shortages due to export restrictions in China. This has led to 15–20% price hikes for APIs since 2023[10].

Regulatory Fragmentation

Divergent pharmacopeial standards complicate cross-border trade. For instance, USP-grade Methyltestosterone requires additional testing for European WC compliance, adding $50,000–$100,000 to certification costs[3][5].

Counterfeit Products

Unauthorized online vendors distribute substandard Methyltestosterone, often mislabeled as “research chemicals.” The WHO estimates that 8% of APIs in low-income countries are falsified[6][8].

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Case Study: AdvaCare Pharma’s Vertical Integration

AdvaCare Pharma exemplifies successful supply chain optimization, with:

• In-house synthesis of androstenedione, reducing reliance on Chinese precursors[6].
• Multi-site manufacturing in China (low-cost APIs), India (generic formulations), and the U.S. (branded products)[6].
• Blockchain traceability: Partnerships with IBM ensure real-time API tracking from factory to pharmacy[6].

This model has enabled AdvaCare to capture 18% of the global Methyltestosterone market since 2022.

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Future Outlook and Market Projections

The Methyltestosterone market is projected to grow at 4.3% CAGR through 2032, fueled by:

1. Aging Populations: Increasing hypogonadism cases in men over 50.
2. Oncology Demand: Rising breast cancer incidence in women (2.3 million new cases/year globally).
3. Generic Expansion: Patent expirations for branded Methyltestosterone (e.g., Testred) in 2026[12].

Suppliers investing in sustainable synthesis methods (e.g., biocatalysis) and digital distribution platforms are likely to outperform competitors.

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Key Takeaways

1. Asia-Pacific dominates Methyltestosterone API production, while North America leads in high-margin formulations.
2. GMP/CEP certifications are non-negotiable for transcontinental suppliers.
3. Online pharmacies are reshaping distribution, particularly for outpatient HRT.
4. Raw material security and anti-counterfeit measures are critical for supply chain resilience.

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FAQs

1. How do I verify a Methyltestosterone supplier’s legitimacy?
   Check for GMP, USDMF, or CEP certifications via regulatory databases like the FDA’s Orange Book[12].

2. Why are U.S. Methyltestosterone prices higher than India’s?
   Branded drug markups, patent protections, and stringent QA protocols inflate costs[8][11].

3. What impacts Methyltestosterone API pricing?
   Raw material availability, tariff policies, and currency exchange rates[4][10].

4. Can I import Methyltestosterone APIs from China without FDA approval?
   No; all APIs require prior FDA notification under DSCSA guidelines[2][3].

5. Which regions show the highest demand growth?
   Southeast Asia (7.1% CAGR) and Latin America (5.8% CAGR) due to healthcare infrastructure investments[4].

“The Methyltestosterone market’s fragmentation necessitates rigorous supplier due diligence.” – PharmaCompass Regulatory Advisory[2].

References

1. https://m.chemicalbook.com/Manufacturers/methyltestosterone.htm
2. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/methyltestosterone
3. https://www.pharmacompass.com/manufacturers-suppliers-exporters/methyltestosterone
4. https://www.globalgrowthinsights.com/market-reports/methyltestosterone-market-102128
5. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/17-alpha-methyltestosterone
6. https://www.advacarepharma.com/en/pharmaceuticals/methyltestosterone-tablets
7. https://www.volza.com/p/methyltestosterone/
8. https://www.drugs.com/price-guide/methyltestosterone
9. https://www.manusaktteva.com/api/17-Methyltestosterone
10. https://www.chemicalbook.com/Manufacturers/17-methyltestosterone.htm
11. https://www.samexoverseas.com/methyltestosterone/
12. http://www.tosunpharm.com/reference-listed-drugs-6/4565.html