Suppliers and packagers for norpramin

norpramin

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399	NDA	Validus Pharmaceuticals LLC	30698-007-01	100 TABLET, SUGAR COATED in 1 BOTTLE (30698-007-01)	1964-11-20
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399	NDA	Validus Pharmaceuticals LLC	30698-011-01	100 TABLET, SUGAR COATED in 1 BOTTLE (30698-011-01)	1964-11-20
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399	NDA	Validus Pharmaceuticals LLC	30698-015-01	100 TABLET, SUGAR COATED in 1 BOTTLE (30698-015-01)	1964-11-20

Suppliers for the Pharmaceutical Drug: Norpramin

Last updated: July 29, 2025

Introduction

Norpramin, the brand name for the generic drug Desipramine, is a tricyclic antidepressant primarily prescribed for depression and certain anxiety disorders. Its interplay within the pharmaceutical supply chain involves a network of manufacturers, generic drug producers, and distributors. This article provides an in-depth overview of the key suppliers involved in the manufacturing and distribution of Norpramin, analyzing their roles and market positioning to assist pharmaceutical companies, healthcare providers, and investors in understanding the drug's supply landscape.

Overview of Norpramin and Its Market

Desipramine was first introduced in the 1960s and became a staple in depression treatment. While brand-name Norpramin is produced by pharmaceutical companies such as Perrigo and Impax Laboratories, the broader market for Desipramine includes numerous generic manufacturers. The global demand for antidepressants has contributed to a dynamic and competitive supplier environment, with multiple entities engaged in the production of Desipramine active pharmaceutical ingredients (APIs) and finished dose forms.

Key Suppliers of Norpramin (Desipramine)

1. Active Pharmaceutical Ingredient (API) Manufacturers

The foundation of Norpramin's supply chain lies in the production of Desipramine's API. Multiple global chemical and pharmaceutical companies manufacture this critical component, with quality, regulatory compliance, and capacity being pivotal factors.

• Xianju Fragrant Rabbit Pharmaceutical Co., Ltd. (China)
  A notable API producer, Xianju provides Desipramine API to various generic manufacturers. It benefits from extensive Chinese pharmaceutical manufacturing infrastructure, ISO certifications, and competitive pricing strategies.

• Mitsubishi Tanabe Pharma Corporation (Japan)
  While primarily focused on other compounds, Mitsubishi Tanabe has historically been involved in producing high-quality APIs, including certain antidepressants, adhering to strict Japanese regulatory standards (PMDA). Their capacity for high-purity API production makes them a key supplier for premium formulations.

• PKC Group (India)
  India’s pharmaceutical sector, notably companies like PKC, supplies Desipramine API to Western and domestic markets. India’s API industry, regulated by the Central Drug Standard Control Organization (CDSCO), features Good Manufacturing Practice (GMP) compliant facilities that serve as a vital source for generics.

• Sun Pharmaceutical Industries Ltd. (India)
  As one of the world's largest generic pharmaceutical companies, Sun Pharma manufactures Desipramine API for export and domestic use, leveraging Indian regulatory standards and extensive manufacturing capacity.

2. Finished Dosage Form Manufacturers

Once APIs are produced, various generic pharmaceutical companies incorporate Desipramine into finished tablets.

• Impax Laboratories (USA)
  Impax is known for producing generic formulations, including Norpramin, with a focus on compliance with U.S. Food and Drug Administration (FDA) standards. The company often sources Desipramine API from established API suppliers and integrates it into final products.

• Hikma Pharmaceuticals (UK/Jordan)
  A major player in generic pharmaceuticals, Hikma produces Norpramin through licensed or in-house formulations, sourcing APIs regionally or globally.

• Teva Pharmaceutical Industries Ltd. (Israel)
  As one of the largest generic drug producers, Teva manufactures Desipramine-based medications, often sourcing from Indian API producers or their own facilities.

• Aurobindo Pharma (India)
  Aurobindo produces various antidepressant generics, including Desipramine, with API sourced from their in-house facilities or reliable external contractors.

3. Distributors and Wholesalers

Distribution channels for Norpramin span global and regional markets, involving reputable pharmaceutical distributors.

• McKesson Corporation (USA)
  McKesson supplies pharmacies and hospitals with Norpramin, sourcing from approved manufacturers in compliance with U.S. regulations.

• AmerisourceBergen (USA)
  As a key distributor, AmerisourceBergen maintains an extensive network for sourcing and delivering Desipramine products to the North American market.

• Celesio (Germany)
  Operating across European markets, Celesio supplies generic antidepressants, including Norpramin, through partnerships with regional manufacturers.

Market Dynamics Influencing Supplier Selection

The supply chain for Norpramin features several influencing factors:

• Regulatory Compliance: Suppliers must meet stringent regulatory standards such as FDA, EMA, and WHO cGMP compliance to ensure product quality, safety, and efficacy.
• Cost Efficiency: Cost-effective sourcing, particularly from Indian and Chinese manufacturers, remains crucial due to competitive pricing pressures.
• Capacity and Reliability: Ensuring consistent API and finished product supply requires suppliers to maintain adequate capacity and robust quality management systems.
• Quality Control and Certification: Suppliers with ISO certifications, current Good Manufacturing Practice (cGMP) compliance, and proven Track Record in quality assurance are preferred.

Challenges and Opportunities in the Norpramin Supply Chain

The supply landscape faces challenges such as geopolitical tensions affecting import/export, supply chain disruptions (notably during COVID-19), and regulatory hurdles. Conversely, emerging markets and advances in manufacturing technologies present opportunities for diversification and increased capacity.

Conclusion

The supply of Norpramin (Desipramine) hinges on a complex network of API producers, finished dose manufacturers, and distributors. Major API suppliers from China, India, and Japan serve as the backbone of the supply chain, with multinational pharmaceutical companies manufacturing the final product in compliance with global regulatory standards. Ensuring supply stability and quality assurance remains essential for meeting ongoing demands worldwide.

Key Takeaways

• The primary API suppliers for Norpramin include Chinese, Indian, and Japanese manufacturers such as Xianju Fragrant Rabbit, Sun Pharma, and Mitsubishi Tanabe, all complying with regulatory standards.
• Global generic producers like Impax, Teva, and Aurobindo play vital roles in converting APIs into finished Norpramin tablets for diverse markets.
• Distribution networks across North America and Europe maintain robust channels to ensure product availability, leveraging strategic partnerships with regulators and quality-certified suppliers.
• Supply chain resilience depends on diversified sourcing, continuous quality assurance, and adaptive strategies amid geopolitical and logistical challenges.
• Regular regulatory updates and market analyses are essential for stakeholders to navigate the evolving landscape effectively.

FAQs

1. Who are the leading API manufacturers for Desipramine used in Norpramin?
Major API producers include Chinese companies like Xianju Fragrant Rabbit Pharmaceutical, Indian firms such as Sun Pharma and Aurobindo, and Japanese companies like Mitsubishi Tanabe. These manufacturers supply high-quality Desipramine API globally.

2. Are generic manufacturers a reliable source of Norpramin?
Yes, reputable generic manufacturers like Impax, Teva, and Hikma maintain strict quality controls, GMP compliance, and regulatory approvals, making them reliable sources for Norpramin and Desipramine formulations.

3. How has recent geopolitical tension affected Norpramin supply chains?
Geopolitical tensions, particularly involving China and India, have prompted diversification of supply sources, increased scrutiny of API manufacturing standards, and at times caused temporary disruptions, emphasizing the need for resilient supply networks.

4. What regulatory standards govern Norpramin manufacturing?
Manufacturers must comply with cGMP requirements of agencies like the FDA, EMA, TPD, and WHO to ensure product safety, efficacy, and quality. Certifications such as ISO 9001 also support supplier credibility.

5. Are there any emerging suppliers or markets for Norpramin?
Emerging markets in Southeast Asia, Eastern Europe, and Latin America are increasingly developing local API and finished product capabilities, offering potential supply diversification avenues for Norpramin stakeholders.

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Sources

1. U.S. Food and Drug Administration (FDA) Drug Database.
2. IMS Health, IQVIA – Global Pharmaceutical Market Analysis.
3. Company websites and annual reports of Xianju Fragrant Rabbit, Sun Pharma, and Impax Laboratories.
4. European Medicines Agency (EMA) guidelines on API manufacturing.
5. Industry reports from GlobalData and EvaluatePharma.