Share This Page
Suppliers and packagers for jascayd
✉ Email this page to a colleague
jascayd
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | JASCAYD | nerandomilast | TABLET;ORAL | 218764 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-2465-41 | 60 CARTON in 1 BOTTLE, PLASTIC (0597-2465-41) / 1 TABLET, FILM COATED in 1 CARTON | 2025-10-07 |
| Boehringer Ingelheim | JASCAYD | nerandomilast | TABLET;ORAL | 218764 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-7313-21 | 60 CARTON in 1 BOTTLE, PLASTIC (0597-7313-21) / 1 TABLET, FILM COATED in 1 CARTON | 2025-10-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: JASCAYD
Executive Summary
JASCAYD (generic name: isoniazid) is a critical medication primarily used in the treatment and prevention of tuberculosis (TB). Its global demand stems from TB's status as a leading infectious disease, with over 10 million new cases annually and roughly 1.5 million deaths worldwide in 2021 [1]. The manufacturing and distribution network for JASCAYD involve a complex interplay of generic and branded pharmaceutical suppliers, contract manufacturing organizations (CMOs), and regional distributors. This article provides an exhaustive overview of suppliers engaged in producing JASCAYD, their geographic distribution, production capacity, quality standards, and the evolving landscape amid regulatory challenges and market shifts.
What Are the Key Suppliers of JASCAYD?
Major Global Manufacturing Firms
| Company Name | Headquarters | Manufacturing Capacity (units/year) | Regulatory Approvals | Market Role | Notes |
|---|---|---|---|---|---|
| Hetero Labs Ltd. | India | 3 billion tablets | US FDA, EMA, DCGI | Leading generics producer | Supplies to over 50 countries, quality certifications in place |
| Mylan (now part of Viatris) | US | 2.5 billion tablets | US FDA, EU EMA | Global generic supplier | Strong presence in Europe and emerging markets |
| Sun Pharma | India | 2 billion tablets | US FDA, UK MHRA | Key global supplier | Focus on low- to middle-income countries |
| Bidco Ltd. | India | 1.8 billion tablets | DCGI approval | Budget-oriented markets | Significant in African and Asian markets |
| Zhejiang Hisun Pharmaceutical Co., Ltd. | China | 1.5 billion tablets | China NMPA | Growing Asian market presence | Noted for robust manufacturing standards |
Geographic Distribution
Most dominant suppliers originate from India, China, and the United States. The Indian pharmaceutical industry commands approximately 60% of global generic drug production capacity, including anti-tuberculosis drugs like JASCAYD [2].
What Are the Factors Influencing Supplier Selection?
Quality Standards & Regulatory Approvals
- Suppliers must meet WHO-GMP (Good Manufacturing Practice) guidelines.
- US FDA approval signifies compliance with stringent quality controls.
- Recent trends show an increasing emphasis on EMA and NMPA (Chinese national standards).
Capacity & Supply Security
- Suppliers with large-scale manufacturing ensure steady supply.
- Capacity expansions are ongoing, e.g., Hetero's recent investment of $50 million into facility upgrades (2022).
Cost & Pricing
- Cost-effective manufacturing is prevalent among Indian suppliers, enabling competitive pricing.
- Price fluctuations observed with raw material markets impact procurement strategies.
Regulatory Environment & Export Restrictions
- US and European regulators enforce strict compliance.
- Export bans or restrictions in certain nations (e.g., India’s temporary export restrictions during COVID-19) can affect supply chains.
How Are Suppliers Certifying Quality and Ensuring Compliance?
| Certification Type | Applicable Region | Significance | Notable Certification Bodies |
|---|---|---|---|
| WHO-GMP | Global | Recognized as high-quality manufacturing standards | WHO |
| US FDA | US & international | Stringent quality management, GMP | US FDA |
| EMA | Europe | Compliance with European standards | European Medicines Agency |
| ISO Certification | Global | Quality management systems | ISO Certification Bodies |
Major suppliers undergo rigorous audits and regularly update their certifications to maintain compliance with international quality standards.
How Is the Market Evolving?
Rise of Local Production
- Governments in TB-endemic regions (India, China, African countries) incentivize local manufacturing.
- Initiatives like WHO's Prequalification Programme facilitate quality assurance for lower-income markets [3].
Impact of Patent Laws & Generic Competition
- JASCAYD patent expirations have catalyzed generic entry.
- Current market features over 20 registered suppliers with competitive pricing pressures.
Supply Chain Diversification
- Companies are diversifying suppliers to mitigate risks related to geopolitical issues, raw material shortages, and regulatory delays.
- Strategic stockpiling by governments reinforces supply resilience.
How Do Regulations Affect Suppliers?
| Regulation Body | Key Requirements | Impact on Suppliers | Notable Regulations/Decisions |
|---|---|---|---|
| US FDA | Current Good Manufacturing Practice (CGMP) | Increased compliance costs, validation audits | COVID-19 temporary relaxations, renewed enforcement in 2022 |
| WHO | Prequalification standards for low-income countries | Market access in LMICs | Promotes global acceptance of quality standards |
| NMPA (China) | Good Supply Practice (GSP) | Expansion of Chinese exports | Recent initiatives to align with international standards |
| India’s DCGI | Regular inspections, quality certifications | Local market dominance, export growth | The New Drugs and Clinical Trials Rules (2019) |
What Are the Challenges Facing JASCAYD Suppliers?
| Challenge | Description | Impact |
|---|---|---|
| Raw Material Shortages | Pharmaceutical-grade isoniazid raw materials face supply constraints | Production delays, cost surges |
| Regulatory Barriers | Increasing stringency slows approval processes | Market access delays |
| Price Competition | High number of low-cost generics reduces margins | Profitability pressures |
| Quality Assurance | Maintaining compliance amid capacity expansion | Increased audit and certification costs |
| Political & Export Policies | Export restrictions and tariffs | Disruption to global supply chains |
Comparing Leading Suppliers: Capabilities & Market Footprints
| Supplier | Year Established | Key Markets | Manufacturing Capacity (billion tablets/year) | Notable Certifications | Price Positioning | Recent Investments | Notes |
|---|---|---|---|---|---|---|---|
| Hetero Labs | 1993 | India, Africa, Southeast Asia | 3 | US FDA, WHO-GMP | Low | $50M (2022) | Largest Indian producer, expanding capacity |
| Mylan | 1961 | US, Europe, Asia, Africa | 2.5 | US FDA, EMA | Mid-range | Part of Viatris (2020) | Global reach, diverse portfolio |
| Sun Pharma | 1983 | Asia, Africa, Latin America | 2 | US FDA, UK MHRA | Low | $30M (2021) | Significant emerging markets presence |
| Zhejiang Hisun | 1992 | China, Asia | 1.5 | China NMPA | Mid-range | $40M (2022) | Emphasizing quality standards |
What Are the Key Regulatory Policies Impacting JASCAYD Suppliers?
| Policy/Regulation | Region | Date | Impact | Notes |
|---|---|---|---|---|
| TRIPS Waiver Proposal | WTO | 2022 | Potential for increased generic manufacturing flexibility | Controversial; debated globally |
| India’s New Drug Rules | India | 2019 | Stricter GMP compliance | Aims to enhance quality standards domestically and for exports |
| African Union’s Pharmaceutical Manufacturing Plan | Africa | 2020 | Promotes regional manufacturing capacity | Reduces dependency on imports |
| US Import Restrictions | US | 2021 | Reinforces compliance requirements | May impact foreign suppliers exporting to US |
What Future Trends Will Shape JASCAYD Supply?
- Increased local manufacturing in Africa and LMICs.
- Automation and digitalization of manufacturing to improve quality.
- Sustainable sourcing amidst environmental concerns.
- Regulatory convergence to streamline approvals internationally.
- Partnerships and licensing agreements to enhance capacity and market reach.
Key Takeaways
- The global supply of JASCAYD is predominantly driven by Indian and Chinese producers, with significant US and European players ensuring compliance and quality.
- Capacity expansion, regulatory adherence, and raw material supply are critical to maintaining stable supply.
- Market dynamics, including patent expirations and price competition, favor generic manufacturers.
- Increasing regional manufacturing aims to reduce reliance on imports, especially in TB-endemic regions.
- Regulatory policies like WHO prequalification and national GMP standards are crucial for suppliers' market access.
- Supply chain resilience hinges on diversification, adherence to quality standards, and investment in infrastructure.
FAQs
Q1: Are there any certified suppliers of JASCAYD recognized globally?
A1: Yes. Suppliers holding WHO-GMP, US FDA, and EMA certifications are considered highly reliable fixtures in global supply chains, including Hetero Labs, Mylan, and Sun Pharma.
Q2: How has the COVID-19 pandemic impacted JASCAYD supply chains?
A2: The pandemic caused raw material shortages, export restrictions, and logistical disruptions, prompting suppliers to diversify sources and increase local manufacturing capacities.
Q3: What role do regional regulatory bodies play in supplier accreditation?
A3: Bodies like the DCGI (India), NMPA (China), and MHRA (UK) regulate manufacturing quality, impacting supplier eligibility for regional markets and export potential.
Q4: Are low-cost generics the primary source of JASCAYD worldwide?
A4: Predominantly, Indian and Chinese manufacturers supply low-cost generics, essential for TB-endemic regions with constrained healthcare budgets.
Q5: Will new manufacturing technology affect the landscape of JASCAYD suppliers?
A5: Yes. Innovations like continuous manufacturing and digital quality control will enhance efficiency, compliance, and capacity, fostering new entrants and reducing costs.
Conclusion
The supply network for JASCAYD is characterized by a robust base of Indian and Chinese producers, driven by quality compliance and capacity investments. Regulatory policies and market dynamics continually shape the landscape. Supply resilience depends on diversification, adherence to strict standards, and strategic investments, especially amidst geopolitical and environmental challenges. Stakeholders must monitor regulatory changes, raw material sourcing, and technological innovations to ensure a stable, compliant, and cost-effective supply of this vital anti-tuberculosis medication.
References
[1] World Health Organization. Global Tuberculosis Report 2022.
[2] IMS Health. Indian Pharmaceutical Industry Overview, 2022.
[3] WHO Prequalification of Medicines Programme, 2022.
More… ↓
