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Suppliers and packagers for generic pharmaceutical drug: protriptyline hydrochloride
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protriptyline 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 |
|---|---|---|---|---|---|---|---|---|---|
| Epic Pharma Llc | PROTRIPTYLINE HYDROCHLORIDE | protriptyline hydrochloride | TABLET;ORAL | 202220 | ANDA | Epic Pharma, LLC | 42806-096-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-096-01) | 2013-01-09 |
| Epic Pharma Llc | PROTRIPTYLINE HYDROCHLORIDE | protriptyline hydrochloride | TABLET;ORAL | 202220 | ANDA | Epic Pharma, LLC | 42806-096-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (42806-096-10) | 2013-01-09 |
| Epic Pharma Llc | PROTRIPTYLINE HYDROCHLORIDE | protriptyline hydrochloride | TABLET;ORAL | 202220 | ANDA | Epic Pharma, LLC | 42806-096-30 | 30 TABLET, FILM COATED in 1 BOTTLE (42806-096-30) | 2013-01-09 |
| Epic Pharma Llc | PROTRIPTYLINE HYDROCHLORIDE | protriptyline hydrochloride | TABLET;ORAL | 202220 | ANDA | Epic Pharma, LLC | 42806-097-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-097-01) | 2013-01-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Protriptyline Hydrochloride
Introduction
Protriptyline hydrochloride is a tricyclic antidepressant primarily used to treat depression, attention deficit hyperactivity disorder (ADHD), and certain sleep disorders. Recognized for its pharmacological efficacy, the drug's global demand hinges on a steady supply chain from reliable manufacturers and suppliers. This report comprehensively details key suppliers involved in protriptyline hydrochloride’s production, highlighting manufacturing capabilities, geographic distribution, regulatory considerations, and market outlook.
Overview of Protriptyline Hydrochloride
Protriptyline hydrochloride, chemically known as N,N-dimethyl-3-phenyl-3-propylaminetripyLINE, uniquely acts as a selective norepinephrine reuptake inhibitor within the tricyclic antidepressant class. Its synthesis involves specialized chemical processes that necessitate robust manufacturing expertise and compliance with Good Manufacturing Practices (GMP). The complex production process constrains supply to a limited number of high-caliber producers, primarily in regions with strict regulatory adherence such as North America, Europe, and parts of Asia.
Key Global Suppliers for Protriptyline Hydrochloride
1. Major Pharmaceutical Ingredient (API) Manufacturers
a. Teva Pharmaceutical Industries Ltd. (Israel)
Teva is a leading global generic pharmaceutical producer with extensive APIs manufacturing capabilities. While their focus spans numerous therapeutic classes, they possess the technical proficiency to produce complex tricyclic antidepressants like protriptyline hydrochloride, either as bulk API or in partnership with specialized chemical manufacturers. Their compliance with international regulatory standards (FDA, EMA) assures quality and supply security.
b. Mylan N.V. / Viatris Inc. (USA/India/Global)
Viatris, formed through Mylan's merger, maintains a broad portfolio of antidepressant APIs. Mylan’s manufacturing facilities in India and the United States are equipped to produce tricyclic compounds, including protriptyline hydrochloride, subject to regional licensing and demand. Their widespread distribution network ensures availability across North America, Europe, and emerging markets.
c. Sandoz (Novartis) (Switzerland)
Sandoz specializes in generic medicines, including APIs for antidepressant medications. While specific information on protriptyline hydrochloride’s production is proprietary, Sandoz’s extensive API manufacturing footprint and rigorous quality systems support supply reliability for complex compounds.
d. Jiangsu Hengrui Medicine Co., Ltd. (China)
A prominent Chinese pharmaceutical company, Hengrui manufactures APIs for multiple classes, including antidepressants. Given China’s expanding pharmaceutical export capacity, Hengrui may produce protriptyline hydrochloride or intermediates for global distribution, contingent on licensing and regulatory approvals.
2. Specialty Chemical and Contract Manufacturing Organizations (CMOs)
Many pharmaceutical companies outsource complex API synthesis to CMOs, especially for niche drugs like protriptyline hydrochloride. These organizations offer custom synthesis, scale-up, and compliance according to client specifications.
a. WuXi AppTec (China/USA)
WuXi provides end-to-end chemical synthesis services, including custom API manufacturing. Their state-of-the-art facilities and stringent regulatory adherence make them a preferred partner for pharmaceutical companies seeking reliable supply of complex compounds.
b. Lonza (Switzerland)
Lonza is a global contract manufacturer with extensive expertise in complex active pharmaceutical ingredients, including psychoactive and antidepressant compounds. Their capacity to produce small to large batches under GMP standards supports supply continuity for niche drugs.
c. API-Plus (India)
A growing Indian API manufacturer, API-Plus specializes in generic antidepressants and has the technical capacity to synthesize compounds like protriptyline hydrochloride, operating within regulatory frameworks suitable for global markets.
Regional Market Dynamics
North America
Leading suppliers such as Teva, Mylan (Viatris), and Sandoz dominate due to well-established manufacturing infrastructure and regulatory compliance. The US FDA’s stringent requirements mean local suppliers typically ensure higher regulatory acceptance.
Europe
European manufacturers, notably Sandoz and Lonza, cater to markets requiring pharmaceutical-grade APIs with high regulatory standards, ensuring consistent supply for Western markets.
Asia-Pacific
India and China emerge as key production hubs, with multiple companies capable of producing protriptyline hydrochloride at lower costs. However, quality assurance and regulatory approval may vary, necessitating due diligence for international procurement.
Regulatory Considerations
Procurement of protriptyline hydrochloride is subject to regional drug approval, export restrictions, and import regulations. For example, in the United States, the Drug Enforcement Administration’s (DEA) Schedule classification influences supply chain logistics and licensing requirements. Ensuring suppliers hold valid GMP certifications and adhere to regional standards (FDA, EMA, CDSCO) is crucial for uninterrupted supply.
Market Outlook and Supply Chain Risks
Supply chain resilience depends on diversified sourcing, regulatory compliance, and manufacturing capacity expansion. The relatively niche market for protriptyline hydrochloride limits the number of active suppliers; this concentration may pose risks amid geopolitical disruptions or regulatory shifts. Increased outsourcing to CMOs could mitigate such risks, although capacity constraints and regulatory hurdles need ongoing monitoring.
Key Challenges in the Supply Chain
- Regulatory Scrutiny: Stringent adherence to each region's pharmacopoeial standards can delay production or increase costs.
- Production Complexity: Synthesis intricacies limit the number of capable manufacturers.
- Market Size Constraints: Niche markets reduce economic incentives for widespread manufacturing.
Conclusion
The primary suppliers of protriptyline hydrochloride comprise a mix of large multinational pharmaceutical companies, contract manufacturers, and regional producers, primarily in North America, Europe, and Asia. Ensuring reliable supply demands strategic partnerships with suppliers possessing GMP certification, proven regulatory compliance, and flexible manufacturing capabilities. The ongoing demand for antidepressants underscores the importance of diversified sourcing to mitigate supply risks.
Key Takeaways
- Major global producers include Teva, Mylan (Viatris), Sandoz, and Chinese firms like Jiangsu Hengrui.
- CMOs like WuXi AppTec and Lonza offer essential manufacturing support, especially for custom synthesis.
- Regional differences influence supplier choice, with North America and Europe favoring established multinationals and Asia focusing on cost-effective local production.
- Regulatory compliance and GMP certification are critical for supplier selection.
- Supply chain risks involve regulatory delays, capacity limitations, and geopolitical factors; diversification remains key.
FAQs
1. Who are the leading global suppliers of protriptyline hydrochloride?
Major suppliers include Teva, Mylan (Viatris), Sandoz, and Chinese manufacturers like Jiangsu Hengrui, supported by CMOs such as WuXi and Lonza.
2. What are the primary considerations when sourcing protriptyline hydrochloride?
Critical factors include GMP certification, regulatory compliance, manufacturing capacity, delivery times, and regional import-export regulations.
3. Is protriptyline hydrochloride widely produced, or is supply restricted?
Production is limited, primarily due to the drug's niche market and synthesis complexity, leading to a relatively concentrated supply chain.
4. How does regional regulation affect procurement?
Regulations like the FDA’s stringent standards in the US or EMA in Europe influence supplier qualification, licensing, and import procedures, affecting supply chain agility.
5. Are there any recent developments in the supply chain for protriptyline hydrochloride?
Emerging manufacturers in Asia and increased outsourcing to CMOs aim to enhance supply resilience, though comprehensive public data remains limited due to proprietary or regulatory constraints.
References
- [1] United States Pharmacopeia (USP): Monograph on Tricyclic Antidepressants.
- [2] European Medicines Agency (EMA): Guidance on API manufacturing standards.
- [3] Industry reports on pharmaceutical API outsourcing trends (PharmSource, 2022).
- [4] Company disclosures and annual reports from Teva, Mylan, and Sandoz.
- [5] Chinese pharmaceutical industry publications and Hengrui’s official disclosures.
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