Suppliers and packagers for generic pharmaceutical drug: TERAZOSIN HYDROCHLORIDE

TERAZOSIN 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
Ajanta Pharma Ltd	TERAZOSIN HYDROCHLORIDE	terazosin hydrochloride	CAPSULE;ORAL	219482	ANDA	Ajanta Pharma USA Inc.	27241-288-01	100 CAPSULE in 1 BOTTLE (27241-288-01)	2025-05-12
Ajanta Pharma Ltd	TERAZOSIN HYDROCHLORIDE	terazosin hydrochloride	CAPSULE;ORAL	219482	ANDA	Ajanta Pharma USA Inc.	27241-288-10	1000 CAPSULE in 1 BOTTLE (27241-288-10)	2025-05-12
Ajanta Pharma Ltd	TERAZOSIN HYDROCHLORIDE	terazosin hydrochloride	CAPSULE;ORAL	219482	ANDA	Ajanta Pharma USA Inc.	27241-289-01	100 CAPSULE in 1 BOTTLE (27241-289-01)	2025-05-12

Suppliers for the Pharmaceutical Drug: Terazosin Hydrochloride

Last updated: July 29, 2025

Introduction

Terazosin Hydrochloride is a widely prescribed medication used primarily for the treatment of benign prostatic hyperplasia (BPH) and hypertension. As a selective alpha-1 adrenergic receptor blocker, it alleviates urinary symptoms associated with prostate enlargement and lowers blood pressure. Given its broad therapeutic application, the drug commands a significant global market, prompting a robust supply chain of active pharmaceutical ingredients (APIs) and finished dosage forms. Understanding the key suppliers—a mix of ingredient manufacturers, contract manufacturing organizations (CMOs), and distributors—is critical for stakeholders across pharmaceuticals, healthcare, and biotech sectors.

Global Supply Landscape for Terazosin Hydrochloride

The availability of Terazosin Hydrochloride hinges on several factors including API manufacturing capability, regulatory compliance, and distribution networks. The market’s perennial demand ensures a competitive landscape with suppliers spanning multiple continents, notably Asia, Europe, and North America.

Major API Manufacturers

1. Teva Pharmaceutical Industries

Teva, an Israel-based pharmaceutical giant, is among the leading global suppliers of Terazosin Hydrochloride APIs. They possess an extensive manufacturing network adhering to global regulatory standards, including FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) compliance. Their capacity to produce high-quality APIs hinges on their robust R&D and manufacturing infrastructure.

2. Hetero Labs Limited

An Indian pharmaceutical powerhouse, Hetero is recognized for cost-effective API manufacturing with a focus on high-volume generics. They produce Terazosin Hydrochloride API and boast compliance with international quality standards, including ICH Q7 guidelines, making them a reliable supplier for global markets.

3. Suzhou Huatian Pharmaceutical Co., Ltd.

Based in China, this manufacturer supplies APIs compatible with the international quality requirements. They have gained prominence through aggressive R&D investments and partnerships, making their APIs a competitive choice for generic manufacturers.

4. Mylan N.V. (now part of Viatris)

Mylan, a global leader in generics and biosimilars, has established manufacturing facilities capable of producing Terazosin Hydrochloride APIs. Their rigorous quality controls and broad distribution channels allow for widespread availability in North America and Europe.

Key Contract Manufacturing Organizations (CMOs)

In addition to direct API manufacturers, several CMOs serve the pharmaceutical industry by producing finished dosage forms or synthesizing APIs on behalf of brand owners:

• Granules India Ltd. (India) – Known for high-volume production of active ingredients, including Terazosin Hydrochloride APIs, catering mainly to the generic drug sector.
• Amol Pharmaceuticals (India) – Offers contract manufacturing for finished dosage forms and API synthesis compliant with GMP standards.
• Venus Remedies (India) – Engaged in both API manufacturing and formulation development, with a substantial global export footprint.

Distribution and Key Suppliers of Finished Dosage Forms

Once APIs are produced, pharmaceutical companies and wholesalers distribute Terazosin Hydrochloride tablets globally. Leading distributors include:

• McKesson Corporation (USA)
• Cardinal Health (USA)
• Fresenius Kabi (Germany)
• NHU (North Huaian Pharmaceutical) (China)

These entities source from multiple API suppliers to ensure supply chain resilience, competitive pricing, and regulatory compliance.

Regulatory and Quality Considerations

Suppliers of Terazosin Hydrochloride must adhere to stringent quality standards. Most reputable API manufacturers hold current certifications such as:

• FDA approval/inspection reports
• ISO 9001 certification
• ICH Q7 Good Manufacturing Practice (GMP) compliance
• European Pharmacopoeia compliance

Failure to meet these benchmarks can cause disruptions in supply and affect product quality, influencing market stability.

Emerging Suppliers and Market Dynamics

The increasing emphasis on cost efficiency and localized manufacturing in emerging markets has propelled newer entrants from India, China, and Eastern Europe into the Terazosin supply chain. Technological advancements in synthesis and process optimization have lowered manufacturing costs, making it feasible for smaller players to enter the market.

Additionally, potential future disruptions—such as raw material shortages, geopolitical factors, or regulatory changes—pose risks to supply security. Therefore, global pharma companies often diversify their supplier base, engaging multiple sources for API procurement.

Key Challenges in Sourcing Terazosin Hydrochloride

• Regulatory Compliance: Ensuring suppliers meet international standards
• Supply Chain Disruptions: Raw material shortages or production delays
• Price Volatility: Fluctuations owing to raw material costs or geopolitical tensions
• Quality Assurance: Maintaining consistent API quality across batches

Conclusion

The supply chain for Terazosin Hydrochloride is characterized by a diverse pool of global manufacturers, with leading players in India, China, and established Western markets. Large pharmaceutical firms maintain stringent supplier qualification processes to mitigate risks, ensure regulatory compliance, and maintain uninterrupted supply. Market entrants continue to emerge, driven by global demand and technological advances. Stakeholders—including drug developers, formulators, and distributors—must prioritize supply chain resilience and regulatory adherence to sustain reliable access to this vital therapeutic agent.

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Key Takeaways

• Leading API suppliers for Terazosin Hydrochloride include Teva, Hetero Labs, Suzhou Huatian, and Viatris, primarily from North America, India, and China.
• Contract manufacturing organizations like Granules India and Venus Remedies play a crucial role in the finished dosage form supply chain.
• Suppliers are required to meet international quality, safety, and regulatory standards, including GMP and ICH guidelines.
• The market dynamics are influenced by geopolitical factors, raw material availability, and evolving regulatory landscapes, necessitating diversified sourcing strategies.
• Ensuring rigorous qualification processes and quality control is essential for mitigating supply risks associated with Terazosin Hydrochloride.

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FAQs

1. Who are the top global suppliers of Terazosin Hydrochloride API?
Major suppliers include Teva Pharmaceutical Industries (Israel), Hetero Labs (India), Suzhou Huatian Pharmaceutical (China), and Viatris (formerly Mylan), all adhering to international quality standards.

2. What are the key regulatory certifications required for suppliers of Terazosin Hydrochloride?
Suppliers should possess GMP compliance certifications from agencies like the FDA and EMA, along with ISO 9001 and ICH Q7 certifications to ensure product quality and safety.

3. How do geopolitical factors impact the supply of Terazosin Hydrochloride?
Trade policies, tariffs, political stability, and raw material access can influence supply continuity, pricing, and supplier reliability.

4. What role do contract manufacturing organizations play in the supply chain?
CMOs synthesize APIs or produce finished formulations on behalf of pharmaceutical companies, expanding manufacturing capacity and enabling flexible sourcing options.

5. What are the challenges faced by healthcare providers in sourcing Terazosin Hydrochloride?
Challenges include ensuring consistent API quality, managing supply disruptions, complying with regulatory standards, and controlling costs amidst market volatility.

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References

1. [1] U.S. Food & Drug Administration. API Manufacturing Oversight.
2. [2] ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
3. [3] GlobalData. Pharmaceutical API Market Overview.
4. [4] MarketWatch. Global Terazosin Hydrochloride Market Analysis.
5. [5] Indian Pharmaceutical Association. API Production and Regulations.