Who makes Suboxone? Discover the Leading Manufacturers13 min read

Are you curious about Suboxone and its production? In this article, we will delve into the world of Suboxone, an essential medication for addiction treatment. Not only will you learn about its active ingredients and purpose, but we will also explore the key companies responsible for manufacturing Suboxone. Let’s uncover the vital details and shed light on the efforts behind this life-changing medication.

  • Understand the Purpose of Suboxone: Learn about the significance of Suboxone in addiction treatment and how it helps individuals on their path to recovery.
  • Explore the Active Ingredients: Discover the roles of Buprenorphine and Naloxone in Suboxone and their importance in the treatment process.
  • Get to Know the Leading Manufacturers: Dive into the backgrounds and contributions of the primary companies involved in Suboxone production.
  • Unveil Quality Control Measures: Learn about the strict regulations and quality control practices these manufacturers adhere to.
  • Ensure Safe Usage: Understand the guidelines for patients and medical professionals to ensure safe and effective usage of Suboxone.
  • Stay Informed on Research and Development: Explore ongoing efforts to improve Suboxone and develop alternative forms and dosages.

The Purpose of Suboxone in Addiction Treatment

Suboxone plays a crucial role in addiction treatment, particularly for individuals struggling with opioid dependency. This medication is a combination of two active ingredients: Buprenorphine and Naloxone. Buprenorphine, a partial opioid agonist, helps alleviate withdrawal symptoms and cravings without causing the same intense euphoria as other opioids. Naloxone, on the other hand, is an opioid antagonist that blocks the effects of opioids and serves to prevent misuse.

The Leading Manufacturers of Suboxone

Three prominent companies are responsible for the production of Suboxone: Indivior Inc., Mylan Pharmaceuticals Inc., and Roxane Laboratories Inc.

Indivior Inc.

Indivior Inc. is a leading player in the addiction treatment space. With a strong focus on research and development, the company has dedicated efforts to create innovative medications that address the complex challenges of opioid addiction.

  • Company Background and Mission: Indivior Inc. was founded with the mission to provide effective and accessible treatments for opioid dependence and related disorders.
  • Role in Suboxone Production: The company is one of the pioneers in producing Suboxone, a critical medication in the journey to recovery.
  • Regulations and Quality Control: Indivior Inc. strictly adheres to FDA guidelines and maintains high-quality standards in manufacturing Suboxone.

Mylan Pharmaceuticals Inc.

Mylan Pharmaceuticals Inc. is known for its commitment to making medications more affordable and accessible to people worldwide.

  • Overview of Mylan Pharmaceuticals: Mylan has a significant presence in the pharmaceutical industry and is renowned for its focus on generic medications.
  • Involvement in Suboxone Manufacturing: Mylan collaborates with Suboxone developers and invests in research to improve the medication.
  • Ensuring Accessibility and Distribution: The company adopts strategies to ensure that Suboxone is available to those who need it.

Roxane Laboratories Inc.

Roxane Laboratories Inc., a part of the Hikma Pharmaceuticals group, has been actively engaged in producing Suboxone.

  • About Roxane Laboratories: Roxane has a long history in the pharmaceutical industry and has expanded its capabilities in various therapeutic areas.
  • Contributions to Suboxone Production: The company’s manufacturing expertise plays a crucial role in providing a stable supply of Suboxone.
  • Collaboration with Healthcare Providers: Roxane collaborates with healthcare professionals to ensure that patients receive the right support during treatment.

The Role of Buprenorphine in Suboxone

Buprenorphine, as one of the active ingredients in Suboxone, plays a vital role in addiction treatment. Being a partial opioid agonist, it binds to the same receptors in the brain as other opioids, but its effects are milder. This property helps individuals gradually reduce their opioid dependence without experiencing intense withdrawal symptoms. Buprenorphine’s slow onset and long duration of action contribute to its effectiveness in stabilizing patients during treatment.

Benefits and Limitations of Buprenorphine

The use of buprenorphine in Suboxone offers several advantages. Its ceiling effect reduces the risk of overdose and abuse, making it safer for patients undergoing addiction treatment. Additionally, buprenorphine can be prescribed in various formulations, including sublingual tablets and films, catering to individual preferences and needs.

However, like any medication, buprenorphine has some limitations. It may interact with other medications, and its administration requires careful monitoring to avoid potential side effects. Medical professionals must educate patients about the proper usage and storage of Suboxone containing buprenorphine to ensure optimal treatment outcomes.

Benefits of Buprenorphine in Suboxone:

  • Reduced Withdrawal Symptoms: Buprenorphine eases the discomfort of opioid withdrawal, helping patients remain committed to their treatment plan.
  • Lower Risk of Overdose: Due to its partial agonist properties, buprenorphine carries a lower risk of overdose compared to full opioid agonists.
  • Flexibility in Formulations: Buprenorphine can be administered in various forms, making it convenient for patients and healthcare providers.

Limitations of Buprenorphine in Suboxone:

  • Potential Drug Interactions: Buprenorphine may interact with other medications, necessitating careful monitoring and adjustment of treatment plans.
  • Adverse Reactions: Some individuals may experience side effects such as nausea, constipation, or headache during buprenorphine treatment.
  • Storage and Safety: Proper storage of Suboxone is crucial to prevent accidental ingestion by children or unauthorized individuals.

The Role of Naloxone in Suboxone

Naloxone, the second active ingredient in Suboxone, serves as an essential safety component. As an opioid antagonist, naloxone blocks the effects of opioids on the brain’s receptors, helping prevent misuse and overdose. When Suboxone is taken as directed, naloxone remains inactive, allowing buprenorphine to alleviate withdrawal symptoms. However, if someone attempts to misuse Suboxone by injecting it, naloxone becomes active, blocking the effects of buprenorphine and other opioids.

Preventing Misuse and Overdose with Naloxone

Naloxone’s inclusion in Suboxone is a crucial harm reduction strategy. It acts as a safeguard against accidental overdose, offering an additional layer of protection for individuals in recovery. By inhibiting the effects of opioids, naloxone discourages the misuse of Suboxone and promotes responsible medication usage.

Key Features of Naloxone in Suboxone:

  • Emergency Overdose Reversal: Naloxone rapidly reverses the effects of opioids, providing a life-saving measure in the event of an overdose.
  • Injection Deterrent: Naloxone’s activation upon injection discourages individuals from misusing Suboxone by non-prescribed routes.
  • Enhanced Medication Safety: The presence of naloxone in Suboxone contributes to safer medication practices and reduces the risk of accidental overdose.

Leading Manufacturer: Indivior Inc.

Indivior Inc. takes center stage in the production of Suboxone. With a rich history in addiction treatment, the company has been at the forefront of providing innovative solutions to combat opioid dependency. Indivior’s commitment to research and development has resulted in significant advancements in the formulation and delivery of Suboxone.

Company Background and Mission

Indivior Inc. was established with a clear mission to make a positive impact on public health by offering effective treatments for opioid dependence and related disorders. The company’s founders envisioned a future where individuals could find hope and support on their journey to recovery. Over the years, Indivior has grown into a global leader in the addiction treatment space, collaborating with healthcare providers and policymakers to address the opioid crisis.

Indivior’s Contributions to Suboxone Production:

  • Research and Development Excellence: Indivior’s dedicated research teams have continually explored new avenues to improve Suboxone’s efficacy and safety.
  • Patient-Centric Approach: The company places patients’ well-being at the forefront of its efforts, ensuring that Suboxone meets their specific needs and preferences.
  • Focus on Access and Affordability: Indivior strives to make Suboxone accessible to a wide range of individuals seeking treatment for opioid addiction.

Leading Manufacturer: Mylan Pharmaceuticals Inc.

Mylan Pharmaceuticals Inc. is another key player in Suboxone production. The company’s dedication to providing affordable medications has extended to addiction treatment, making Suboxone more accessible to those in need.

Overview of Mylan Pharmaceuticals

Mylan Pharmaceuticals has a strong presence in the global pharmaceutical market. Known for its extensive portfolio of generic medications, the company has played a significant role in improving access to essential treatments worldwide. Mylan’s commitment to affordability aligns well with the goal of making Suboxone available to as many people as possible.

Mylan’s Efforts in Suboxone Manufacturing:

  • Partnerships for Progress: Mylan collaborates with Suboxone developers and suppliers to ensure a continuous supply of the medication.
  • Investments in Research and Innovation: The company invests in research to improve Suboxone’s formulation and delivery methods.
  • Global Distribution Network: Mylan’s extensive distribution network helps make Suboxone accessible in various regions around the world.

Leading Manufacturer: Roxane Laboratories Inc.

Roxane Laboratories Inc., a subsidiary of the Hikma Pharmaceuticals group, is a significant contributor to Suboxone production.

About Roxane Laboratories

Roxane Laboratories has a long-standing history in the pharmaceutical industry, with a focus on providing high-quality medications to meet various therapeutic needs. As part of Hikma Pharmaceuticals, Roxane leverages the group’s expertise and resources to support Suboxone production and distribution.

Roxane’s Contributions to Suboxone Production:

  • Manufacturing Excellence: Roxane’s state-of-the-art manufacturing facilities ensure the production of high-quality Suboxone medications.
  • Continuous Product Improvement: The company is committed to refining Suboxone formulations to enhance patient outcomes.
  • Collaboration with Healthcare Providers: Roxane works closely with healthcare professionals to raise awareness about Suboxone’s benefits and proper usage.

Quality Control Measures for Suboxone

Ensuring the safety and efficacy of Suboxone is of utmost importance to the manufacturers. Stringent quality control measures are implemented throughout the production process to maintain the medication’s integrity and consistency. From raw material testing to final product analysis, every step is subject to thorough scrutiny and compliance with regulatory standards.

Compliance with FDA Guidelines

The U.S. Food and Drug Administration (FDA) sets strict guidelines for pharmaceutical manufacturing, including Suboxone. Manufacturers like Indivior, Mylan Pharmaceuticals, and Roxane Laboratories adhere to these regulations to obtain FDA approval and maintain their credibility as reliable pharmaceutical companies.

Key Quality Control Practices:

  • Batch Testing and Analysis: Each batch of Suboxone undergoes comprehensive testing to ensure it meets predetermined specifications.
  • Environmental Monitoring: Cleanroom environments are regularly monitored to prevent contamination during production.
  • Validation and Calibration: Equipment used in Suboxone manufacturing is regularly validated and calibrated to maintain accuracy.

Guidelines for Safe Usage of Suboxone

The responsible and safe use of Suboxone is essential for successful addiction treatment. Healthcare providers play a vital role in guiding patients through the treatment process and ensuring they follow the prescribed regimen.

Qualifications for Prescribing Suboxone

Medical professionals who are authorized to prescribe Suboxone must meet specific qualifications and undergo specialized training. This ensures that patients receive appropriate care and support during their treatment journey.

Guidelines for Healthcare Providers:

  • Assessment and Patient Selection: Healthcare providers carefully assess patients to determine their suitability for Suboxone treatment.
  • Induction and Maintenance Phases: Providers follow specific protocols for Suboxone induction and maintenance, tailoring treatment plans to individual needs.
  • Monitoring and Dose Adjustment: Regular follow-ups help monitor progress and make necessary adjustments to Suboxone dosage.

Guidelines for Suboxone Patients

Patients receiving Suboxone treatment also have a responsibility to ensure its effectiveness and safety.

Understanding Proper Usage

Patients are educated about the correct way to take Suboxone, emphasizing its sublingual administration and potential risks associated with misuse.

Key Points for Patients:

  • Sublingual Administration: Suboxone should be placed under the tongue for optimal absorption, as swallowing the medication reduces its effectiveness.
  • Adherence to Prescribed Dosage: Patients must strictly adhere to their prescribed dosage to maintain stable treatment and avoid potential side effects.
  • Reporting Side Effects: Any unusual or concerning side effects should be promptly reported to the healthcare provider for evaluation.

Research and Development of Suboxone

Research and development efforts surrounding Suboxone continue to evolve to improve the medication’s effectiveness and patient experience. These initiatives focus on finding new formulations, delivery methods, and alternative dosages that cater to individual needs.

Advancements in Suboxone Formulations

Researchers explore innovative ways to enhance Suboxone formulations, aiming for improved patient compliance and better treatment outcomes. Efforts include developing sublingual films with enhanced bioavailability and extended-release formulations that require less frequent dosing.

Promising Developments:

  • Sublingual Films vs. Tablets: Suboxone sublingual films provide faster onset and dissolve more quickly, making them a convenient alternative to traditional tablets.
  • Extended-Release Formulations: Extended-release Suboxone formulations offer prolonged relief, reducing the frequency of daily dosing and enhancing patient convenience.

Ensuring Accessibility and Distribution of Suboxone

Making Suboxone accessible to those who need it is crucial for effective addiction treatment. Manufacturers collaborate with distributors and healthcare providers to ensure a smooth and efficient distribution process.

Supply Chain and Distribution Network

Manufacturers work diligently to establish a robust supply chain and distribution network to reach various regions and healthcare facilities. This effort is vital for meeting the increasing demand for Suboxone worldwide.

Efforts in Accessibility:

  • Global Distribution Channels: Manufacturers leverage global distribution networks to reach patients in different countries and regions.
  • Affordable Pricing Strategies: Pricing models and strategies are developed to make Suboxone affordable and accessible to individuals from diverse socioeconomic backgrounds.


In conclusion, Suboxone plays a pivotal role in addiction treatment, offering a safer and more controlled approach to overcoming opioid dependence. Leading manufacturers such as Indivior Inc., Mylan Pharmaceuticals Inc., and Roxane Laboratories Inc. have dedicated significant efforts to ensure the quality and accessibility of Suboxone. With ongoing research and development, Suboxone continues to evolve, providing hope and support to those seeking a path to recovery from opioid addiction.

Frequently Asked Questions (FAQs) about Suboxone

1. What is Suboxone, and how does it work?

Suboxone is a medication used to treat opioid dependence. It contains two active ingredients, Buprenorphine and Naloxone. Buprenorphine helps reduce withdrawal symptoms and cravings, while Naloxone prevents misuse and overdose.

2. Is Suboxone safe to use for addiction treatment?

Yes, Suboxone is considered safe when used as prescribed by a qualified healthcare provider. Its unique formulation with Naloxone helps reduce the risk of overdose and misuse.

3. How do I start Suboxone treatment?

To start Suboxone treatment, you need to consult a healthcare provider who is authorized to prescribe it. They will conduct an assessment to determine if Suboxone is the right option for your addiction treatment.

4. What is the duration of Suboxone treatment?

The duration of Suboxone treatment varies depending on individual needs and progress. Some individuals may require short-term treatment, while others may benefit from longer-term maintenance.

5. Can I take Suboxone while pregnant?

Pregnant individuals should consult their healthcare provider before starting or continuing Suboxone treatment. In some cases, healthcare professionals may recommend continuing treatment to support a healthy pregnancy.

6. Can I drive or operate machinery while taking Suboxone?

Suboxone may cause drowsiness or dizziness in some individuals, especially during the initial stages of treatment. It is essential to exercise caution when driving or operating heavy machinery until you know how Suboxone affects you.

7. Are there any potential side effects of Suboxone?

Like any medication, Suboxone may have side effects. Common side effects include headache, nausea, constipation, and sleep disturbances. It is essential to report any unusual or severe side effects to your healthcare provider.

8. Can I abruptly stop taking Suboxone?

Abruptly stopping Suboxone is not recommended, as it may lead to withdrawal symptoms. It is essential to work closely with your healthcare provider to develop a tapering plan when discontinuing Suboxone.

9. Can Suboxone be used for pain management?

Suboxone is primarily indicated for addiction treatment and is not typically used for pain management. There are other medications more suitable for pain relief.

10. Is Suboxone addictive?

When taken as prescribed under the guidance of a healthcare provider, Suboxone has a lower potential for addiction compared to other opioids. However, it is crucial to follow the prescribed dosage and not misuse the medication.