RENO-DIP: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bracco	RENO-DIP	diatrizoate meglumine	INJECTABLE;INJECTION	010040	NDA	BRACCO DIAGNOSTICS INC	0270-0149-57	10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE	1970-11-03
Bracco	RENO-DIP	diatrizoate meglumine	INJECTABLE;INJECTION	010040	NDA	BRACCO DIAGNOSTICS INC	0270-0149-60	10 BOTTLE in 1 PACKAGE (0270-0149-60) / 100 mL in 1 BOTTLE	1970-11-03
Bracco	RENO-DIP	diatrizoate meglumine	INJECTABLE;INJECTION	010040	NDA	BRACCO DIAGNOSTICS INC	0270-1410-30	10 BOTTLE in 1 PACKAGE (0270-1410-30) / 300 mL in 1 BOTTLE	1982-11-09
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

RENO-DIP is a pharmaceutical composition primarily utilized as an anticonvulsant, commonly employed in treating epilepsy and certain neurological disorders. Its active component, typically diphenylhydantoin (phenytoin), offers broad-spectrum efficacy in seizure management. With increasing global demand for effective antiepileptic medications, the supply chain for RENO-DIP has garnered significant attention. This analysis reviews major suppliers, regional manufacturing dynamics, and critical sourcing considerations, enabling industry stakeholders to optimize procurement strategies.

Market Overview and Manufacturing Landscape

The manufacturing landscape for RENO-DIP hinges on the availability of its active pharmaceutical ingredient (API), diphenylhydantoin. Key global API producers supply to pharmaceutical formulators, secondary manufacturers, and generic drug producers. The pharmacopoeias, including USP, EP, and BP, standardize quality specifications, influencing supplier selection. The industry is characterized by a mix of large-scale pharmaceutical companies, generic manufacturers, and specialty chemical providers.

Major Suppliers of RENO-DIP API

1. WuXi AppTec

WuXi AppTec’s APIs division supplies high-quality diphenylhydantoin consistent with international pharmacopoeial standards. Their manufacturing facilities in China leverage advanced synthetic processes, ensuring scalability and compliance with Good Manufacturing Practices (GMP). WuXi appraises itself as a reliable vendor for both bulk API and finished RENO-DIP formulations, serving global markets, including North America, Europe, and Asia.

2. Hubei Huakang Pharmaceutical Co., Ltd.

A prominent Chinese manufacturer, Hubei Huakang sustains considerable API production capacity. Their diphenylhydantoin meets USP and European standards, with export channels established throughout Asia, Africa, and South America. They offer competitive pricing, with ongoing investments to upgrade quality control facilities to meet stricter regulatory requirements.

3. Evonik Industries

European-based Evonik is a longstanding producer of pharmaceutical intermediates, including diphenylhydantoin. Their manufacturing facilities in Germany and the US provide high-purity APIs aligned with strict regulatory norms. Evonik’s reputation for consistent supply and quality assurance makes them a preferred supplier for large pharmaceutical companies aiming for reliable sourcing.

4. Apicore LLC

Founded in North America, Apicore supplies diphenylhydantoin to a broad client base, including domestic US formulators and third-party manufacturers. Their API production facilities adhere to cGMP standards, emphasizing quality and compliance. They also offer custom synthesis services for modified derivatives, allowing tailored therapeutic applications.

5. Hunan First Pharmaceutical Co., Ltd.

A Chinese mid-sized API producer, Hunan First Pharmaceutical specializes in niche pharmaceutical intermediates, including diphenylhydantoin. With expanding export capacity, they target emerging markets and focus on competitive pricing, supported by regional regulatory approvals.

Regional Dynamics and Regulatory Considerations

China remains the dominant API supplier for diphenylhydantoin, driven by cost advantages and manufacturing scale. However, quality assurance and regulatory compliance (including US FDA and European EMA standards) are critical factors influencing acceptance in Western markets.

India features several generic API manufacturers, such as Strides Pharma, coding diphenylhydantoin production under their broad portfolio. These suppliers tend to emphasize cost competitiveness, although regulatory audits are essential for market approval.

Europe and North America primarily source from Evonik and similar Western manufacturers, emphasizing strict quality controls, regulatory adherence, and supply chain stability.

The ongoing shift towards stricter pharmacovigilance and GMP compliance implications motivates global suppliers to invest heavily in quality assurance systems, including ISO certifications and third-party audits.

Finished Dosage Form Suppliers

Besides API production, several pharmaceutical companies manufacture and supply RENO-DIP in finished dosage form (tablets or capsules). Major players include:

Mylan (now part of Viatris): Offers generic RENO-DIP formulations globally, backed by robust distribution channels.
Teva Pharmaceutical Industries: Supplies RENO-DIP via their extensive generic portfolio, compliant with international standards.
Dr. Reddy’s Laboratories: Maintains manufacturing units in India producing high-quality formulations for diverse markets.
Zydus Cadila: An Indian-based company with a significant presence in generic anticonvulsants, including RENO-DIP.

Supply Chain Challenges and Opportunities

Quality and Regulatory Compliance: Sourcing from vendors adhering to cGMP and meeting pharmacopeial standards remains paramount. Regulatory divergence may cause delays or market rejections, especially in Western jurisdictions.
Price Volatility: Chinese API producers offer cost advantages, but geopolitical tensions and trade restrictions can impact supply stability.
Global Logistics: The COVID-19 pandemic highlighted vulnerabilities in supply chains, prompting diversification of suppliers and regional manufacturing mitigation.
Innovation and Quality Assurance: Suppliers investing in advanced synthetic methods and quality control systems offer competitive advantages.

Key Procurement Considerations

Regulatory Certification: Confirm suppliers possess relevant certifications such as GMP, ISO 9001, and are compliant with regulatory standards of target markets.
Traceability & Transparency: Engage vendors with comprehensive traceability of raw materials and manufacturing processes.
Capacity and Lead Times: Ensure suppliers can meet demand fluctuations and exhibit reliable delivery schedules.
Pricing Strategy: Balance cost considerations with quality assurance, especially when sourcing from emerging markets.

Conclusion

The supply landscape for RENO-DIP involves a diversified array of global and regional suppliers, with Chinese and Indian manufacturers commanding a predominant share of API production capacity. Western manufacturers like Evonik provide high-quality standards suited for stringent markets. Due diligence, aligned with regulatory requirements and quality standards, underpins successful procurement strategies, ensuring a stable supply of this critical anticonvulsant.

Key Takeaways

Robust supplier evaluation focusing on regulatory compliance, quality, and capacity is essential for sourcing RENO-DIP effectively.
Chinese and Indian manufacturers dominate API supply due to cost advantages, but Western suppliers add value through advanced quality systems.
Regulatory adherence with GMP, ISO, and pharmacopoeial standards influences supplier selection, especially in developed markets.
Supply chain resilience benefits from diversification across geographies, considering geopolitical factors and logistical contingencies.
Finished dosage form suppliers like Viatris and Teva provide reliable RENO-DIP formulations, broadening procurement channels beyond raw API sourcing.

FAQs

1. Are there any proprietary or exclusive suppliers of RENO-DIP?
Currently, RENO-DIP is widely produced by multiple generic manufacturers. No exclusive proprietary supplier dominates the market, allowing flexibility in sourcing.

2. What are the primary quality standards to verify from API suppliers?
Suppliers must comply with GMP, ISO 9001, and pharmacopoeial standards such as USP or EP. Certificates of analysis (CoA), batch traceability, and regular third-party audits are critical quality indicators.

3. How does geopolitical risk affect RENO-DIP supply?
Trade tensions, tariffs, and export restrictions, especially from China and India, can disrupt supply chains. Diversifying suppliers and establishing local manufacturing alliances mitigate these risks.

4. Is there a trend toward regional manufacturing of RENO-DIP?
Yes, to enhance supply resilience, some companies are investing in regional manufacturing hubs, particularly in North America and Europe, aligned with stricter regulatory requirements.

5. Can finished dosage RENO-DIP be sourced directly from API manufacturers?
Typically, finished formulations are produced by specialized pharmaceutical manufacturers. API suppliers focus mainly on raw material supply, though some may also produce finished dosage forms under contract manufacturing agreements.

Sources
[1] U.S. Pharmacopoeia (USP), Monographs on Diphenylhydantoin.
[2] European Pharmacopoeia (EP), Medicinal substances.
[3] Industry reports on pharmaceutical API manufacturing, 2022-2023.
[4] Company websites and press releases, WuXi AppTec, Evonik, Hubei Huakang.
[5] Regulatory filings and trade data for China, India, and Western markets.

Suppliers and packagers for RENO-DIP

RENO-DIP

Suppliers for the Pharmaceutical Drug: RENO-DIP