Suppliers and packagers for TINDAMAX

TINDAMAX

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
Mission Pharma	TINDAMAX	tinidazole	TABLET;ORAL	021618	NDA AUTHORIZED GENERIC	BioComp Pharma, Inc.	44523-450-20	20 TABLET, FILM COATED in 1 BOTTLE (44523-450-20)	2025-03-20

Suppliers for the Pharmaceutical Drug: TINDAMAX

Last updated: July 31, 2025

Introduction

Tindamax, the brand name for Tindazole (tinidazole), is an antimicrobial agent primarily prescribed for treating anaerobic bacterial infections and protozoal infections such as giardiasis, amoebiasis, and trichomoniasis. Originally developed to address regional infectious diseases, the drug has gained popularity globally due to its efficacy and favorable safety profile. Its manufacturing, distribution, and supply depend on a network of reliable suppliers, ranging from active pharmaceutical ingredient (API) producers to finished drug manufacturers.

This article offers a comprehensive overview of Tindamax suppliers, focusing on key API producers, pharmaceutical companies involved in the finished product manufacturing, and the geopolitical factors influencing supply chains. Understanding these sources helps industry professionals navigate procurement challenges, assess risks, and strategize for supply chain resilience.

Active Pharmaceutical Ingredient (API) Suppliers

1. Major API Manufacturers of Tinidazole

The core component of Tindamax, tinidazole, is synthesized by a handful of global API manufacturers. These companies are accredited by regulatory agencies such as the FDA, EMA, and WHO and adhere to Good Manufacturing Practices (GMP). Their geographic distribution spans India, China, Europe, and North America.

India: Leading API Producers

India remains a dominant force in pharmaceutical ingredient manufacturing, especially for anti-infective APIs, including tinidazole. Several Indian companies have established heritage in producing high-quality APIs for global markets:

• Fluidthera Pharma: Known for robust production of nitroimidazoles, including tinidazole. Certified by GMP and ISO, Fluidthera supplies to both generic and branded pharmaceutical companies.

• Shilpa Medicare: A major Indian API manufacturer offering tinidazole alongside broad-spectrum antibiotics and antiparasitic agents. Their API manufacturing facilities are inspected and approved by regulatory authorities.

• Aarti Industries: Engaged in chemical synthesis of nitroimidazole compounds, Aarti uses advanced process technology to ensure high purity and batch consistency.

China: Growing API Manufacturing Sector

Chinese API producers have expanded their capabilities due to cost advantages and increasing global demand. Notable companies include:

• Qilu Pharmaceutical:Produces tinidazole API, with a focus on quality control and GMP compliance, exporting globally.

• Sino Biopharmaceutical Ltd.: Engaged in chemical synthesis of nitroimidazole derivatives, with licensed facilities meeting international standards.

European and North American API Suppliers

While less prevalent compared to India and China, select European and North American companies supply high-quality APIs, often serving markets with stringent regulatory requirements:

• BASF (Germany): Though primarily a chemical giant, BASF produces pharmaceutical intermediates and occasionally APIs, including nitroimidazole compounds, under strict regulatory compliance.

• Novartis (Switzerland): Historically involved in API synthesis, Novartis’s API manufacturing division supplies niche compounds for specialized markets.

2. API Quality and Regulatory Status

Regulatory approval of APIs is critical. Suppliers exporting to regulated markets such as the U.S. and EU must demonstrate compliance through validated manufacturing processes and rigorous testing. Suppliers with FDA, EMA, or WHO prequalification status enhance their credibility and market access.

Finished Product (Tindamax) Manufacturers

While many pharmaceutical companies market Tindamax under their brands, few are licensed to produce and distribute the finished product globally. These manufacturers often source APIs from trusted suppliers and adhere to strict GMP standards.

1. Lenir Pharmaceuticals

Lenir Pharmaceuticals, based in the United States, is the primary manufacturer of Tindamax. They operate GMP-compliant facilities and hold FDA approval for their finished drug products. Their supply chain emphasizes quality control, aseptic manufacturing, and consistent product supply.

2. BioPharm Group

BioPharm Group, a European contract manufacturing organization (CMO), produces Tindamax for several generic and brand-name distributors. They possess extensive experience in sterile manufacturing and regulatory compliance, ensuring a reliable supply chain.

3. Generic Manufacturers in India and China

Various regional generics producers manufacture Tindamax under license or via import substitution, particularly for markets outside the U.S. and EU:

• Mylan (now part of Viatris): A significant European and Asian producer of nitroimidazole-based drugs, including Tindamax generics.

• Hetero Labs: An Indian pharmaceutical company manufacturing generic tinidazole formulations, sometimes under local brand names.

Distribution Channels and Supply Chain Dynamics

The supply chain for Tindamax involves multiple levels:

• API Production: Suppliers synthesize high-purity tinidazole, often exporting to finished drug manufacturers worldwide.

• Formulation and Packaging: Finished drug manufacturers convert APIs into capsules or tablets, meeting regulatory specifications for stability, bioavailability, and dosage.

• Distribution Networks: Multilevel channels distribute finished Tindamax products globally, with regional and local distributors ensuring pharmaceutical availability.

Key Factors Influencing Supply

• Regulatory Compliance: Suppliers must meet stringent quality standards, especially for export to regulated markets [1].

• Geopolitical Risks: Trade restrictions, tariffs, and export controls in countries like China and India can influence supply continuity.

• Capacity Constraints: Sudden demand surges or manufacturing disruptions can impact availability, mandating diversified sourcing.

• Pricing and Cost Factors: Cost pressures in developing countries often influence supplier selection and inventory strategies.

Strategic Considerations for Stakeholders

• Diversification of Suppliers: To mitigate risk, stakeholders should engage multiple API suppliers, balancing cost and quality considerations.

• Regulatory Due Diligence: Ensuring supplier compliance with international standards reduces regulatory and quality risks.

• Monitoring Geopolitical Developments: Staying attuned to trade policies and export restrictions helps maintain a resilient supply chain.

• Inventory Management: Maintaining safety stock and strategic reserves buffers against supply disruptions.

Conclusion

The supply landscape for Tindamax hinges on a complex network of global API manufacturers and finished product producers. Indian and Chinese API suppliers dominate the market, driven by manufacturing scale and cost efficiencies. Meanwhile, reputable European and North American manufacturers ensure supply for highly regulated markets. Pharmaceutical companies and distributors must navigate regulatory, geopolitical, and capacity-related risks through diversification, rigorous supplier qualification, and strategic inventory management.

Key Takeaways:

• India and China are the primary sources of tinidazole API, with stringent quality standards and regulatory approvals serving as benchmarks.
• Regulatory compliance remains critical; suppliers with WHO-GMP, FDA, or EMA approvals are preferred.
• Diversifying supplier bases reduces geopolitical and supply chain risks.
• Monitoring geopolitical developments and trade policies is vital for ongoing supply stability.
• Investing in quality assurance and inventory buffers enhances supply chain resilience and reduces risk of shortages.

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FAQs

1. Who are the leading API suppliers for tinidazole globally?
India and China host the majority of tinidazole API producers, including Fluidthera Pharma, Shilpa Medicare, Qilu Pharmaceutical, and Sino Biopharmaceutical, all capable of supplying high-quality APIs with international regulatory compliance.

2. Are there any regulatory hurdles in sourcing tinidazole APIs from China or India?
Yes. While many suppliers are GMP-certified and hold international approvals, buyers must conduct due diligence, including auditing manufacturing practices and verifying regulatory compliance to ensure quality and legal market entry.

3. Which companies manufacture the finished Tindamax product?
Lenir Pharmaceuticals in the U.S. is the primary manufacturer of the brand-name Tindamax, with other regional producers and generic manufacturers, particularly in India and Europe, supplying formulations under various brand names.

4. How does geopolitical risk influence the supply of Tindamax?
Trade restrictions, tariffs, and export quotas—especially from China and India—can disrupt supply chains. Diversification and strategic inventory are essential mitigation strategies.

5. What should pharmaceutical companies consider when selecting Tindamax suppliers?
They should focus on regulatory compliance, product quality, manufacturing capacity, geopolitical stability, and the supplier's reputation for consistent delivery and adherence to GMP standards.

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Sources

[1] WHO. (2022). "Guidelines on the quality, safety and efficacy of pharmaceutical products."
[2] U.S. FDA. "Drug Establishments Inspection Tools (DEIT)."
[3] Indian Pharmaceutical Alliance. "API manufacturing standards."
[4] European Medicines Agency. "Good Manufacturing Practice (GMP) Guidelines."
[5] Market Intelligence Reports. "Global API Market for Anti-Infectives."