Suppliers and packagers for generic pharmaceutical drug: lofexidine hydrochloride

lofexidine hydrochloride

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msn	LOFEXIDINE HYDROCHLORIDE	lofexidine hydrochloride	TABLET;ORAL	218699	ANDA	Novadoz Pharmaceuticals LLC	72205-246-42	1 BOTTLE in 1 CARTON (72205-246-42) / 36 TABLET, FILM COATED in 1 BOTTLE	2025-02-24
Msn	LOFEXIDINE HYDROCHLORIDE	lofexidine hydrochloride	TABLET;ORAL	218699	ANDA	Novadoz Pharmaceuticals LLC	72205-246-43	1 BOTTLE in 1 CARTON (72205-246-43) / 96 TABLET, FILM COATED in 1 BOTTLE	2025-02-24
Novitium Pharma	LOFEXIDINE HYDROCHLORIDE	lofexidine hydrochloride	TABLET;ORAL	219917	ANDA	ANI Pharmaceuticals, Inc.	70954-909-10	36 TABLET in 1 BOTTLE (70954-909-10)	2025-10-22

Suppliers for the Pharmaceutical Drug: Lofexidine Hydrochloride

Last updated: July 28, 2025

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Introduction

Lofexidine hydrochloride emerges as a vital pharmaceutical agent primarily used in managing opioid withdrawal symptoms. As the opioid crisis intensifies globally, pharmaceutical companies and healthcare providers seek reliable sources of lofexidine hydrochloride to meet the rising demand. Identifying dependable suppliers, understanding their manufacturing capabilities, regulatory status, and market positioning are crucial for stakeholders aiming to ensure drug availability, compliance, and cost-effectiveness.

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Overview of Lofexidine Hydrochloride

Lofexidine hydrochloride, a centrally acting alpha2-adrenergic receptor agonist, is marketed under the brand name Lucemyra in the United States. It is used to reduce withdrawal symptoms associated with opioid detoxification. The compound's synthesis involves specialized chemical processes, and sourcing involves navigating a landscape of raw material providers, contract manufacturers, and distributors operating under strict regulatory standards like FDA, EMA, and WHO Good Manufacturing Practices (GMP).

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Major Manufacturers and Suppliers

1. Contract Manufacturing Organizations (CMOs)

Most lofexidine hydrochloride production is conducted via contract manufacturing, often outsourced to specialized facilities with capabilities for complex API synthesis.

• Aenova Group:
  Based in Germany, Aenova supplies APIs and finished dosage forms for global markets. The company boasts a robust GMP-compliant manufacturing infrastructure capable of producing lofexidine hydrochloride at scale.

• VHB Life Sciences:
  An India-based CMO with a proven track record in synthesizing complex APIs, including alpha-2 adrenergic agonists. Their facilities comply with international regulatory standards, catering to both branded and generic pharmaceutical companies.

• CordenPharma:
  Operating in Europe and the US, CordenPharma provides high-quality APIs for neuropharmacology, including lofexidine hydrochloride, emphasizing stringent quality control and supply chain reliability.

2. Raw Material and Active Pharmaceutical Ingredient (API) Suppliers

Procurement of lofexidine hydrochloride relies on chemical suppliers providing high-purity intermediates and the final API.

• Taj Pharmaceuticals:
  An Indian pharmaceutical company, Taj supplies lofexidine hydrochloride to global clients, with established export channels and compliance with international standards.

• Alfa Aesar (Thermo Fisher Scientific):
  A well-known supplier of research chemicals and APIs, Alfa Aesar offers lofexidine hydrochloride for research and development purposes, with potential for pharmaceutical-grade sourcing.

• Tokyo Chemical Industry (TCI):
  TCI supplies chemical reagents, including components used in lofexidine synthesis. While not directly providing finished API, their chemicals are crucial in initial synthesis steps.

3. Specialized API Manufacturers

• Shandong Xinhua Pharmaceutical Co., Ltd.:
  Based in China, this manufacturer produces lofexidine hydrochloride at large scale, serving both domestic and exported markets, emphasizing competitive pricing and regulatory compliance.

• Hunan Kang viral Pharmaceutical Co., Ltd.:
  Focused on neuropharmacological APIs, their lofexidine production aligns with stringent quality standards and QC protocols.

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Regulatory and Supply Chain Considerations

Ensuring a reliable supply of lofexidine hydrochloride necessitates compliance with regulatory standards set forth by authorities such as the FDA, EMA, and WHO. Suppliers with WHO-GMP certification or those approved by the FDA exhibit higher credibility, reducing risks of supply disruptions and regulatory sanctions.

Given the complex synthesis process, supply chain robustness is critical. Political stability, trade policies, and manufacturing capacity can influence availability, making diversified sourcing strategies essential.

Market Dynamics and Sourcing Trends

The market for lofexidine hydrochloride remains niche but expanding due to increased opioid addiction treatments. The entry of generic formulations amplifies demand for reliable API suppliers. Chinese and Indian manufacturers dominate the supply landscape owing to their cost advantages and manufacturing capacities, though compliance and quality control remain critical for pharmaceutical companies.

Furthermore, global initiatives like the WHO's prequalification program influence supplier credibility, prompting companies to prioritize GMP-certified suppliers aligned with international standards.

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Emerging Suppliers and Future Outlook

Innovation in synthesis methods, such as green chemistry approaches, could streamline lofexidine hydrochloride production, diminishing reliance on traditional synthesis pathways. Additionally, new entrants from emerging markets are expanding capacity and competition. Continuous regulatory audits and certifications are pivotal for suppliers aiming to sustain long-term contracts in this niche.

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Conclusion

The supply chain for lofexidine hydrochloride comprises a mix of specialized CMOs, raw material suppliers, and regional manufacturers predominantly based in India, China, and Europe. While established players like Taj Pharmaceuticals, Shandong Xinhua, and VHB Life Sciences dominate, ongoing market expansion and logistical considerations necessitate vigilant supplier evaluation, emphasizing regulatory compliance, manufacturing capacity, and supply flexibility.

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Key Takeaways

• The primary suppliers of lofexidine hydrochloride include global contract manufacturing organizations (CMOs) such as Aenova, VHB, and CordenPharma, with production hubs in Europe, India, and China.
• Indian and Chinese API manufacturers like Taj Pharmaceuticals and Shandong Xinhua are leading low-cost suppliers, integrated into global supply chains.
• Regulatory certification (GMP, WHO prequalification, FDA approval) remains fundamental for suppliers operating in the pharmaceutical supply chain.
• Diversification of sourcing across multiple suppliers mitigates risks associated with geopolitical, regulatory, and capacity-related disruptions.
• Advancements in green synthesis and emerging providers are poised to reshape the accessibility and cost structure of lofexidine hydrochloride in the global market.

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FAQs

Q1: Is lofexidine hydrochloride exclusively supplied by specific regional manufacturers?
No, while India and China are dominant due to cost and capacity advantages, European manufacturers like CordenPharma also supply high-quality lofexidine hydrochloride globally, adhering to strict regulatory standards.

Q2: What should companies consider when selecting a lofexidine hydrochloride supplier?
Regulatory compliance (GMP, FDA approval), manufacturing capacity, supply chain stability, quality assurance protocols, and certification status are critical factors influencing supplier selection.

Q3: Are there alternative sources for lofexidine hydrochloride in the market?
Yes, emerging manufacturers from Southeast Asia and Eastern Europe are entering the market, expanding options for buyers seeking diverse and reliable sources.

Q4: How does regulatory approval impact the supply of lofexidine hydrochloride?
Regulatory approval ensures manufacturing adherence to quality and safety standards, which is essential for global distribution and reduces the risk of supply disruptions.

Q5: What is the future outlook for lofexidine hydrochloride suppliers?
Demand growth driven by opioid withdrawal therapies will likely increase supplier competition, with a focus on process innovation, quality, and regulatory compliance to meet global needs.

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References

1. U.S. Food and Drug Administration. (2023). Lucemyra (Lofexidine) Prescribing Information.
2. Pharmacopoeia of India, Indian Pharmacopoeia Commission. (2022). Standards for Lofexidine Hydrochloride.
3. WHO Prequalification Programme. (2022). Guidelines for API manufacturing practices.
4. Global Market Insights. (2023). Pharmaceutical API Market Trends.
5. Company websites and disclosures: Aenova, VHB Life Sciences, Taj Pharmaceuticals, Shandong Xinhua.