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Suppliers and packagers for generic pharmaceutical drug: PIOGLITAZONE HYDROCHLORIDE
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PIOGLITAZONE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-151-02 | 6 CARTON in 1 TRAY (64764-151-02) / 1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK | 1999-07-15 |
| Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-151-04 | 30 TABLET in 1 BOTTLE (64764-151-04) | 1999-07-15 |
| Takeda Pharms Usa | ACTOS | pioglitazone hydrochloride | TABLET;ORAL | 021073 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-151-05 | 90 TABLET in 1 BOTTLE (64764-151-05) | 1999-07-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Pioglitazone Hydrochloride
Introduction
Pioglitazone Hydrochloride is an oral antidiabetic agent primarily used to manage type 2 diabetes mellitus. Belonging to the class of thiazolidinediones, it functions as an insulin sensitizer, improving glycemic control. The global demand for Pioglitazone Hydrochloride has surged alongside the growing prevalence of diabetes, prompting a competitive landscape among pharmaceutical suppliers. Identifying reliable suppliers is crucial for pharmaceutical companies, generic drug manufacturers, and healthcare providers aiming to secure quality-assured ingredients at optimal costs.
Market Overview and Demand Dynamics
The global pharmaceutical market for Pioglitazone Hydrochloride is robust, driven by increasing awareness of diabetes management and expanding access to affordable medications. The compound is available both as a branded drug and a generic product, with many suppliers producing active pharmaceutical ingredients (APIs) in compliance with international quality standards. As regulatory requirements tighten worldwide, suppliers are compelled to adhere to Good Manufacturing Practices (GMP), ensuring high purity and consistency.
The demand is particularly strong in regions like North America, Europe, and parts of Asia-Pacific, which have significant diabetic populations. The rise of biosimilar and generic manufacturing further amplifies the supply chain's competitiveness, creating opportunities for new entrants and established players.
Leading Suppliers of Pioglitazone Hydrochloride
1. Dr. Reddy’s Laboratories
Overview: An Indian multinational pharmaceutical company, Dr. Reddy's Laboratories produces Pioglitazone Hydrochloride APIs for both branded and generic formulations. The company adheres to stringent quality standards, with a global presence spanning North America, Europe, and Asia.
Strengths:
- Robust GMP compliance
- Extensive R&D capabilities for process optimization
- Proven track record in API manufacturing
Market Presence: Strong supplier for generics markets; supplies to numerous pharmaceutical partners globally.
2. Zydus Cadila
Overview: Zydus Cadila, also based in India, is a key player in the production of diabetes medications, including Pioglitazone Hydrochloride APIs. The company emphasizes innovative manufacturing techniques and compliance with international quality benchmarks.
Strengths:
- Cost-effective manufacturing
- Wide portfolio of diabetes-related APIs
- Certification for US FDA, EMA, and other regulatory bodies
Market Presence: Supplies to international markets and private-label manufacturers.
3. Hetero Labs
Overview: Hetero Labs is recognized for its extensive portfolio in generic drugs and APIs, including Pioglitazone Hydrochloride. The company emphasizes reverse-engineering and process innovation to meet diverse regulatory standards.
Strengths:
- Strong API manufacturing infrastructure
- Focus on scalable, high-quality production
- International export capabilities
Market Presence: Prominent in emerging markets, with expanding footprints in regulated markets.
4. Jiangsu Hengrui Medicine Co., Ltd.
Overview: A leading Chinese pharmaceutical company, Jiangsu Hengrui produces high-quality APIs, including Pioglitazone Hydrochloride, targeting both domestic and international markets.
Strengths:
- Large-scale manufacturing facilities
- ISO and GMP certifications
- Competitive pricing and consistent quality
Market Presence: Growing presence in Asia, with increasing export activities.
5. Lianyungang Jiaer Pharmaceutical Co., Ltd.
Overview: Specialized in the manufacturing of various APIs, Jiaer Pharma supplies Pioglitazone Hydrochloride with a focus on regulatory approval in global markets.
Strengths:
- Strict GMP compliance
- Emphasis on customer-specific formulations
- Cost-effective supply chain management
Market Presence: Serves both domestic and international clients, including the United States and Europe.
6. Other Notable Suppliers
- Mithra Pharmaceuticals (Belgium): Known for high-quality APIs and advanced process chemistry.
- Wuhan Wuchang Pharmaceutical Chemical Co., Ltd: Emphasizes research and development for novel manufacturing processes.
- Sun Pharmaceutical Industries Ltd.: A major Indian producer of APIs, including Pioglitazone Hydrochloride, focusing on global export.
Criteria for Evaluating Suppliers
When selecting a Pioglitazone Hydrochloride supplier, buyers should consider:
- Regulatory Compliance: Certifications (GMP, FDA, EMA, ISO).
- Manufacturing Capacity: Ability to meet short-term and long-term demands.
- Quality Assurance: Purity levels, batch consistency, stability data.
- Pricing Strategies: Competitive costs aligned with quality standards.
- Supply Chain Reliability: On-time delivery, lead times, and logistical support.
- R&D Capabilities: Ability to adapt to formulations or regulatory changes.
Regulatory and Quality Considerations
Suppliers must demonstrate compliance with international standards, especially when supplying to markets like the U.S. (FDA), Europe (EMA), and Japan (PMDA). API quality certifications, stability data, impurity profiles, and batch reproducibility are critical metrics. Due diligence also involves verifying suppliers’ quality management systems and their ability to withstand audits.
Emerging Trends and Opportunities
The global shift towards biosimilars and the increasing availability of generic antidiabetic drugs open new opportunities for API suppliers. Additionally, advancements in green chemistry and sustainable manufacturing practices are gaining traction, prompting suppliers to optimize processes accordingly. However, regulatory barriers remain significant; hence, suppliers investing in robust compliance infrastructures will stand out.
Conclusion
The supply landscape for Pioglitazone Hydrochloride is characterized by a mix of established Indian and Chinese manufacturers, alongside emerging European players. International pharmaceutical companies seeking reliable sourcing should prioritize suppliers with verified GMP certification, proven quality, and capacity to meet regional regulatory standards. Strategic partnerships and stringent supplier qualification processes are essential to ensure uninterrupted supply, consistent quality, and compliance.
Key Takeaways
- Indian firms like Dr. Reddy’s, Zydus Cadila, and Hetero Labs dominate the Pioglitazone Hydrochloride API market, supported by advanced manufacturing and cost competitiveness.
- Chinese companies such as Jiangsu Hengrui and Lianyungang Jiaer are expanding their export footprint through scalable, high-quality production.
- Supply chain due diligence—including regulatory compliance, quality assurance, and delivery reliability—is vital for pharmaceutical companies sourcing APIs.
- Ongoing innovations in green chemistry and manufacturing optimization may influence future supplier offerings.
- Building strategic long-term relationships with reliable, certified suppliers mitigates risks amid evolving regulatory landscapes and market dynamics.
FAQs
1. What are the primary factors to consider when choosing a Pioglitazone Hydrochloride supplier?
Regulatory compliance, manufacturing capacity, product quality, pricing competitiveness, supply chain reliability, and R&D innovation are key considerations.
2. Are domestic manufacturers preferable over international suppliers for Pioglitazone Hydrochloride?
Not necessarily. Both domestic and international suppliers can meet quality and regulatory standards; selection depends on quality certifications, reliability, and cost factors.
3. How does regulatory compliance impact supplier choice?
Suppliers with GMP, FDA, EMA, or ISO certifications ensure product quality and facilitate easier regulatory approval processes for end-users.
4. What trends are shaping the Pioglitazone Hydrochloride API market?
Emerging trends include green manufacturing practices, process innovation, and increasing demand for affordable generics in developing markets.
5. Can new entrants compete with established API manufacturers in the Pioglitazone Hydrochloride market?
Yes, especially if they can demonstrate compliance with quality standards, cost efficiency, and supply reliability, though approval and trust-building take time.
References:
[1] Market analysis reports on active pharmaceutical ingredients (APIs) and antidiabetic drugs.
[2] Industry insights from pharmaceutical manufacturing associations.
[3] Company websites and regulatory filings of key suppliers.
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