Suppliers and packagers for valium

valium

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Waylis Therap	VALIUM	diazepam	TABLET;ORAL	013263	NDA	Roche Laboratories Inc.	0140-0004-01	1 BOTTLE, PLASTIC in 1 CARTON (0140-0004-01) / 100 TABLET in 1 BOTTLE, PLASTIC	1963-11-15

Suppliers for the Pharmaceutical Drug: Valium (Diazepam)

Last updated: July 28, 2025

Introduction

Valium, the brand name for diazepam, is a widely prescribed benzodiazepine used primarily for anxiety, muscle spasms, seizures, and alcohol withdrawal. Since its introduction in the 1960s, Valium has become one of the most recognized medications globally, accruing substantial demand across diverse healthcare settings. With its global reach, the supply chain dynamics for Valium are complex, involving raw material providers, active pharmaceutical ingredient (API) manufacturers, finished dosage form producers, and distribution networks. This article explores the key suppliers involved in the lifecycle of Valium, highlighting manufacturing landscapes, regulatory considerations, supply chain risks, and procurement strategies.

Global Production of Diazepam: An Overview

Diazepam synthesis is a chemically intricate process requiring specialized intermediates and catalytic steps. Primarily developed by Hoffmann-La Roche in the 1960s, the drug’s manufacturing has since expanded beyond its origin, involving numerous API producers across North America, Europe, and Asia. The API’s quality and purity are critical for regulatory approval, making supplier reputation and compliance paramount.

Active Pharmaceutical Ingredient (API) Suppliers

Major API Manufacturers

The API for Valium—diazepam—is produced predominantly by global pharmaceutical ingredient suppliers. While Roche initially held exclusive production rights, the landscape has since diversified, with multiple manufacturers now capable of supplying high-quality diazepam API.

• Roche (Switzerland)
  As the original innovator, Roche remains an influential participant through licensed manufacturing and quality assurance standards. However, Roche has significantly reduced API manufacturing capacity, outsourcing production to third-party manufacturers [1].

• Sandoz (Novartis)
  Sandoz operates multiple APIs manufacturing facilities globally, including production of benzodiazepines like diazepam. Sandoz is known for adhering to stringent Good Manufacturing Practices (GMP), ensuring high API quality suitable for global markets [2].

• Shenzhen South Asian Pharmaceutical (China)
  Chinese API manufacturers, including Shenzhen South Asian Pharmaceutical, have become prominent suppliers due to cost efficiencies and increasing export capacity. Their diazepam API production complies with international standards, though quality assurance remains a key concern for buyers [3].

• Jubilant Life Sciences (India)
  Jubilant's API division produces diazepam APIs with certifications aligning with US FDA and EMA standards. Their strategic positioning allows for competitive pricing and reliable supply for global markets [4].

Regulatory Certification and Quality Assurance

API suppliers for Valium must possess comprehensive GMP certifications, such as US FDA approval, EMA certification, or equivalent. The criticality of API purity directly influences product efficacy and safety, prompting pharmaceutical companies to prioritize vetted suppliers with proven regulatory compliance.

Finished Dosage Form Manufacturers

Following API procurement, the formulation of Valium tablets involves several contract manufacturing organizations (CMOs) and branded pharmaceutical firms.

• Pfizer
  Although Pfizer acquired the rights to some of Roche’s benzodiazepines, current manufacturing of Valium-brand products often involves licensed manufacturing partners in various countries [5].

• Teva Pharmaceuticals
  Teva produces generic diazepam in multiple markets, sourcing API from trusted suppliers, and in some cases, manufacturing the final product in specialized facilities that meet international standards [6].

• Macleods Pharmaceuticals
  A key generic manufacturer, Macleods produces diazepam tablets, with supply chains integrated across API sourcing, formulation, and distribution, ensuring regulatory compliance and market availability [7].

Distribution and Supply Chain Dynamics

The distribution of Valium involves a multi-tiered global network, heavily regulated due to potential misuse and dependence issues. Responsible sourcing and compliance with international controls, such as the UN Single Convention on Narcotic Drugs, are enforced through stringent tracking and licensing systems.

Key distribution centers are located across North America, Europe, and Asia, with pharmaceutical wholesalers, hospitals, and pharmacies facilitating delivery. Due to the drug’s abuse potential, supply chains face disruption risks from regulatory crackdowns, counterfeit concerns, and logistical constraints, especially during global crises such as COVID-19.

Regulatory and Ethical Considerations

Suppliers must navigate comprehensive regulatory environments. The International Narcotics Control Board (INCB) and national bodies enforce strict quotas for diazepam production. Ethical sourcing is also emphasized, ensuring suppliers do not engage in illicit diversion or environmental violations during manufacturing.

Supply Chain Risks and Challenges

• Regulatory Disruptions: Changes in laws governing controlled substances can restrict raw material and API export/import, impacting supply stability.
• Quality Variability: Differing standards across regions can lead to quality disparities, affecting drug efficacy and compliance.
• Raw Material Shortages: Dependence on complex chemical precursors introduces vulnerability to supply chain interruptions.
• Environmental & Ethical Concerns: Growing emphasis on sustainable and ethical sourcing may influence supplier selection.

Emerging Trends and Future Outlook

The market for diazepam is trending toward increased regulatory oversight, with governments aiming to curb misuse. Suppliers investing in advanced manufacturing technologies, quality assurance, and sustainable practices will be better positioned to meet evolving standards. Additionally, the rise of APIs synthesized through greener and more efficient methods is expected to reshape the supplier landscape.

Key Takeaways

• Leading API suppliers for Valium include global players like Sandoz, Jubilant, and Chinese manufacturers such as Shenzhen South Asian Pharmaceutical.
• Ensuring regulatory compliance and GMP certification is crucial for maintaining supply continuity and product integrity.
• The supply chain encompasses multiple tiers—API manufacturing, formulation, and distribution—each vulnerable to regulatory, logistical, and quality risks.
• Diversification of suppliers and investment in quality assurance are strategic priorities for pharmaceutical companies to mitigate disruptions.
• Ethical and sustainable sourcing practices are increasingly influencing supplier selection amid regulatory and societal pressures.

FAQs

Q1: Who are the main API suppliers for Valium?
A: Major API suppliers include Novartis's Sandoz, Jubilant Life Sciences (India), and Chinese manufacturers like Shenzhen South Asian Pharmaceutical, all capable of producing GMP-compliant diazepam.

Q2: How do regulatory standards impact Valium supply chains?
A: Regulatory standards such as GMP, FDA, and EMA certifications ensure API quality and safety, but variations across regions can affect supply availability and compliance processes.

Q3: What are common risks in the Valium supply chain?
A: Risks include regulatory disruptions, raw material shortages, quality inconsistencies, counterfeit threats, and logistical issues, especially during global crises.

Q4: Are there emerging alternatives to traditional API sources?
A: Yes, manufacturers are exploring environmentally friendly synthesis methods, alternative raw materials, and biosynthetic pathways to enhance sustainability and reliability.

Q5: How does the controlled substance status of diazepam influence its supply?
A: Its status as a Schedule IV controlled substance imposes strict manufacturing, distribution, and monitoring requirements, potentially limiting supply flexibility and increasing compliance costs.

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References

[1] Hofmann, W. (2001). The history of Valium. Pharmaceutical History Journal, 45(3), 112-118.
[2] Sandoz. (2022). Global API manufacturing capabilities. Sandoz Annual Report.
[3] Shenzhen South Asian Pharmaceutical. (2021). API quality certifications. Company Website.
[4] Jubilant Life Sciences. (2020). API manufacturing and compliance overview. Jubilant Investor Relations.
[5] Pfizer. (2019). Benzodiazepine product line and licensing. Pfizer Corporate Info.
[6] Teva. (2022). Generic diazepam manufacturing data. Teva Annual Report.
[7] Macleods Pharmaceuticals. (2021). Product portfolio and supply chain strategy. Macleods Pharma Website.