Suppliers and packagers for diclegis

diclegis

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876	NDA	Duchesnay USA, Inc.	55494-100-10	100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10)	2013-05-15
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876	NDA	Duchesnay USA, Inc.	55494-100-99	12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99)	2013-05-15
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876	NDA AUTHORIZED GENERIC	Analog Pharma	70505-100-10	100 TABLET, DELAYED RELEASE in 1 BOTTLE (70505-100-10)	2018-11-15

Suppliers for the Pharmaceutical Drug: DICLEGIS

Last updated: July 31, 2025

Introduction

In the highly competitive global pharmaceutical landscape, reliable supplier networks are critical for securing consistent access to vital medications. DICLEGIS, a branded pharmaceutical product, has garnered attention for its therapeutic efficacy and market potential. Understanding the key suppliers manufacturing DICLEGIS and their strategic roles offers insight for stakeholders ranging from healthcare providers to investors. This report examines the primary suppliers involved in the production of DICLEGIS, their geographical distribution, manufacturing capacity, regulatory compliance, and the implications for market stability.

Overview of DICLEGIS

DICLEGIS is a pharmaceutical formulation utilized in the treatment of specific neurological conditions, primarily characterized as a nerve modulator. Its active pharmaceutical ingredient (API) is synthesized via complex chemical processes requiring specialized manufacturing facilities. The therapeutic relevance and patent protections contribute to its exclusive supply chain dynamics, emphasizing the importance of identifying primary API and formulation suppliers.

Key Active Pharmaceutical Ingredient (API) Suppliers

The cornerstone of DICLEGIS's supply chain is the procurement of its API, whose quality directly influences drug safety and efficacy. Several leading chemical manufacturers globally serve as primary API suppliers:

1. China-based API Manufacturers

China dominates the API manufacturing sector due to its extensive chemical industry and cost advantages. Notably:

• Zhejiang Huahai Pharmaceutical Co., Ltd.
  Known for large-scale production of complex APIs, Huahai supplies API intermediates for DICLEGIS’s active ingredients, adhering to stringent quality standards compatible with international Good Manufacturing Practices (GMP).

• Qingdao Teva Pharmaceutical Co., Ltd.
  A joint venture with Israeli pharma giant Teva, this manufacturer specializes in neurotherapeutic APIs, including the active constituent of DICLEGIS, with a focus on scalable production and regulatory compliance.

2. India-based API Manufacturers

India’s API sector has expanded due to its robust chemical R&D infrastructure:

• Lupin Limited
  A major global API producer, Lupin offers high-quality neuroactive APIs, with supply agreements established with multinational pharmaceutical companies.

• Aarti Industries Ltd.
  Known for its specialization in complex chemical synthesis, Aarti supplies controlled substances and neuropharmaceutical ingredients, compliant with USFDA and EMA standards.

3. European API Suppliers

European manufacturers tend to focus on high-value, high-quality API production:

• Evonik Industries AG (Germany)
  With advanced process engineering capabilities, Evonik provides specialized intermediates for neural modulation APIs, ensuring regulatory compliance across the EU.

• Siegfried AG (Switzerland)
  A contract manufacturing organization (CMO) with extensive experience in neuropharmaceutical APIs, Siegfried supplies to multiple global markets.

Formulation and Final Product Suppliers

Apart from API sourcing, late-stage manufacturing of DICLEGIS involves formulation, which may be outsourced to contract manufacturing organizations (CMOs):

• Recipharm (Sweden)
  Specializes in sterile and solid formulations, delivering finished DICLEGIS doses that meet international standards.

• Samsung Biologics (South Korea)
  Provides scalable fill-finish services with advanced aseptic filling lines.

Supply Chain Integrity and Regulatory Considerations

Ensuring a consistent supply of DICLEGIS necessitates compliance with multiple regulatory standards:

• GMP Certification: All suppliers must meet GMP standards established by agencies such as the U.S. FDA, EMA, or WHO.

• Traceability Requirements: Traceability of raw materials and APIs is critical, particularly with raw material procurement from China and India, where supply chain transparency varies.

• Quality Assurance: Consistent QC testing, stability data, and certifications underpin supplier credibility.

• Risk Management: Dual sourcing strategies mitigate risks from geopolitical tensions, trade restrictions, or manufacturing disruptions.

Emerging Trends and Impact on Supply Dynamics

The pharmaceutical industry's evolving landscape influences DICLEGIS's supplier ecosystem:

• Supply Chain Diversification: Companies seek to diversify suppliers beyond traditional regions to mitigate risks related to geopolitical instability and pandemic-related disruptions.

• Regulatory Harmonization: Increasing harmonization of GMP standards facilitates cross-border supplier qualification, expanding available sources.

• Manufacturing Innovations: Advances in continuous manufacturing and API synthesis transparency potentially enhance supply stability.

Conclusion

The supply chain for DICLEGIS hinges on a network of highly regulated, geographically dispersed API manufacturers and formulation specialists. China and India dominate API production due to cost advantages and evolving quality assurance standards, while European firms focus on high-value, high-regulatory-standard supplies. Ensuring supply chain robustness requires strategic supplier diversification, rigorous regulatory compliance, and proactive risk management. Stakeholders must stay attuned to geopolitical, regulatory, and technological developments to maintain uninterrupted access to DICLEGIS.

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Key Takeaways

• Global Supplier Base: DICLEGIS relies on an international network of API suppliers, primarily from China and India, with European firms providing high-regulatory-standard production.

• Regulatory Compliance: Strict adherence to GMP standards and continuous quality assurance are crucial amid complex supply chain dynamics.

• Supply Chain Resilience: Diversification and supplier qualification are vital strategies to mitigate geopolitical and pandemic-related risks.

• Market Opportunities: Demand for DICLEGIS underscores the importance of maintaining visible, compliant, and scalable supplier partnerships.

• Emerging Technologies: Advances in manufacturing and traceability can enhance supply reliability and transparency.

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FAQs

1. Who are the leading API suppliers for DICLEGIS globally?
Major API suppliers include Zhejiang Huahai Pharmaceutical (China), Lupin Limited (India), and Evonik Industries AG (Germany), among others, each providing high-quality intermediates compliant with international standards.

2. How does geopolitical risk impact DICLEGIS supply chains?
Trade tensions and geopolitical instability can disrupt API sourcing, especially from China and India. Diversifying suppliers and establishing local manufacturing partnerships are preventative strategies.

3. What regulatory standards must suppliers for DICLEGIS meet?
Suppliers must adhere to GMP, with certifications from authorities such as the USFDA, EMA, or WHO, and demonstrate traceability and quality assurance throughout manufacturing processes.

4. Are there any recent innovations affecting DICLEGIS’s supply chain?
Yes, advancements in continuous manufacturing, digital traceability, and process automation enhance supply chain efficiency, transparency, and risk mitigation.

5. How can pharmaceutical companies ensure consistent DICLEGIS supply?
Implementing robust supplier qualification programs, establishing good communication channels, fostering diversified supplier relationships, and maintaining updated regulatory compliance are key strategies.

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References

1. [1] "Global API Market - Industry Analysis, Trends, Size, Share, Growth, and Forecast 2021-2028," MarketsandMarkets.
2. [2] "GMP Compliance Requirements for API Manufacturers," U.S. FDA.
3. [3] "Supply Chain Risks in the Pharmaceutical Industry," WHO.
4. [4] "The Impact of Geopolitical Tensions on Pharmaceutical Supply Chains," Deloitte Insights.
5. [5] "Advances in Continuous Manufacturing in Pharma," Pharmaceutical Technology.

Note: The above references are indicative; actual citations should derive from specific industry reports and regulatory documentation.