Suppliers and packagers for generic pharmaceutical drug: TINIDAZOLE

TINIDAZOLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mission Pharma	TINDAMAX	tinidazole	TABLET;ORAL	021618	NDA	Mission Pharmacal Company	0178-8250-40	40 TABLET, FILM COATED in 1 BOTTLE (0178-8250-40)	2004-05-17
Mission Pharma	TINDAMAX	tinidazole	TABLET;ORAL	021618	NDA	Mission Pharmacal Company	0178-8500-20	20 TABLET, FILM COATED in 1 BOTTLE (0178-8500-20)	2004-05-17
Mission Pharma	TINDAMAX	tinidazole	TABLET;ORAL	021618	NDA	Mission Pharmacal Company	0178-8500-60	60 TABLET, FILM COATED in 1 BOTTLE (0178-8500-60)	2004-05-17
Mission Pharma	TINDAMAX	tinidazole	TABLET;ORAL	021618	NDA AUTHORIZED GENERIC	BioComp Pharma, Inc.	44523-450-12	12 TABLET, FILM COATED in 1 BOTTLE (44523-450-12)	2025-03-20

Suppliers for the Pharmaceutical Drug: Tinidazole

Last updated: July 28, 2025

Introduction
Tinidazole, a nitroimidazole class antiparasitic and antiprotozoal agent, is primarily prescribed for managing infections like amoebiasis, giardiasis, and trichomoniasis. Its broad usage across multiple geographies has driven a global demand, making the supplier landscape a critical point for pharmaceutical manufacturers, distributors, and healthcare providers. This analysis provides an in-depth overview of key suppliers, sourcing dynamics, manufacturing standards, and strategic considerations for stakeholders engaged with Tinidazole procurement.

Overview of Tinidazole Production
Developed in the early 1980s, Tinidazole has become a staple in antiparasitic therapy. The active pharmaceutical ingredient (API) is synthesized via multi-step processes involving nitroimidazole intermediates. Due to its widespread use, several countries host manufacturing facilities capable of producing high-quality Tinidazole, often adhering to stringent Good Manufacturing Practice (GMP) standards.

Major Suppliers and Manufacturers

1. Manufacturer Profiles and Geographic Presence
   Several multinational and domestic companies dominate the Tinidazole API market, including:

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China):
  A leading Chinese pharmaceutical company with extensive experience in anti-infective APIs. Hisun’s production facilities are GMP-compliant, supplying globally.

• Hetero Labs Limited (India):
  A prominent Indian pharmaceutical manufacturer producing Tinidazole API under strict quality standards aligned with regulatory requirements such as USFDA and EMA.

• Glenmark Pharmaceuticals (India):
  An international pharma company with robust API manufacturing capability, including Tinidazole, emphasizing quality and cost competitiveness.

• Ahl Al Maghrib Pharmaceutical (Morocco):
  A regional supplier catering primarily to African markets, with certifications aligning with local and international requirements.

• Jiangxi Bolai Pharmaceutical Co., Ltd. (China):
  A mid-sized manufacturer with GMP-certified facilities, serving mainly Asian and emerging markets.

2. Quality and Regulatory Standards
   Quality assurance remains paramount. Suppliers typically adhere to GMP standards, with certifications from agencies like the USFDA, European EMA, or WHO prequalification. These certifications ensure compliance with purity, potency, and safety regulations essential for global distribution.

3. Supply Chain Dynamics and Market Concentration
   The market for Tinidazole API exhibits consolidation with a few dominant suppliers controlling most manufacturing capacities. Price competition is intense, driven by production scale, regulatory compliance, and geographic factors. Supply chain resilience is increasingly emphasized, especially in the wake of disruptions from geopolitical tensions or COVID-19 pandemic impacts.

Sourcing Strategies for Stakeholders

• Direct Procurement from Manufacturers:
  Engaging directly with certified suppliers ensures control over quality, pricing, and supply stability. This approach necessitates rigorous vendor qualification processes and ongoing quality audits.

• Partnerships with Contract Manufacturing Organizations (CMOs):
  Outsourcing production to reputable CMOs can offer flexibility, cost savings, and scalability while maintaining regulatory compliance.

• Engagement with Distributors and Wholesalers:
  For regional market access, partnering with reliable distributors who source from approved manufacturers may streamline logistics and regulatory clearance, especially in emerging markets.

Regulatory Considerations and Market Access
Suppliers must maintain compliance with local drug registration and import regulations. In major markets such as the US, Europe, and Japan, API importation often requires adherence to stringent documentation, stability testing, and compliance with pharmacopoeia standards (e.g., USP, EP, BP). Recent trends favor suppliers with recognized certifications, reducing regulatory hurdles and expediting time-to-market.

Emerging Trends and Developments

• Biopharmaceutical Innovations:
  Although traditional chemical synthesis remains prevalent, biotechnological advancements could influence future supply chains, emphasizing sustainable and scalable manufacturing methods.

• Environmental and Sustainability Practices:
  Increasing regulatory and consumer pressure incentivizes suppliers to adopt environmentally friendly practices, including waste management and energy-efficient production processes.

• Supply Chain Diversification:
  To mitigate risks, companies are diversifying sourcing strategies, engaging multiple suppliers across regions, and maintaining safety stocks to ensure uninterrupted supply.

Market Outlook

The global Tinidazole API market is projected to grow steadily, driven by increasing parasitic infections in developing regions and expanding indications. The market's stability hinges on maintaining high manufacturing standards, navigating regulatory complexities, and ensuring supply chain resilience.

Key Considerations for Buyers

• Verify supplier certifications (GMP, USFDA, EMA, WHO) before engagement.
• Assess capacity and scalability to meet demand fluctuations.
• Ensure transparent quality control and testing protocols.
• Negotiate terms considering price, delivery timelines, and intellectual property rights.
• Monitor geopolitical and regional regulatory changes affecting supply chains.

Conclusion
The landscape of Tinidazole suppliers consolidates around established pharmaceutical manufacturers committed to quality, regulatory compliance, and reliable supply. Strategic sourcing—aligned with regulatory standards and quality assurance—is essential for stakeholders aiming to optimize procurement, reduce costs, and maintain uninterrupted access to this vital antiparasitic agent.

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Key Takeaways

• Internationally recognized manufacturers like Zhejiang Hisun, Hetero Labs, and Glenmark dominate the Tinidazole API market, offering GMP-compliant products.
• Ensuring supplier certifications and regulatory adherence is critical to mitigating compliance risks.
• Diversification of supply sources and establishing long-term partnerships enhance supply chain resilience.
• Environmental sustainability and technological innovations may influence future supplier capabilities and standards.
• Staying abreast of regulatory changes and market developments is essential for strategic procurement planning.

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FAQs

1. Who are the leading global suppliers of Tinidazole API?
The most prominent suppliers include Zhejiang Hisun Pharmaceutical (China), Hetero Labs (India), and Glenmark Pharmaceuticals (India), each with GMP certification and extensive distribution networks.

2. What quality standards should I prioritize when sourcing Tinidazole?
Suppliers should adhere to GMP standards, with certifications from recognized agencies such as USFDA, EMA, or WHO to ensure API purity, potency, and safety.

3. How does regional regulation affect Tinidazole suppliers?
Regulatory requirements vary; suppliers must comply with local drug registration, importation standards, and pharmacopoeial specifications to facilitate market access.

4. Are there regional suppliers that cater specifically to emerging markets?
Yes, companies like Ahl Al Maghrib Pharma (Morocco) focus on regional markets, offering supply solutions tailored to those jurisdictions.

5. How is market stability for Tinidazole API expected to evolve?
Global demand is forecasted to grow gradually, supported by expanding indications and consistent supply from established manufacturers, provided regulatory and geopolitical factors remain stable.