What is CMC? Drug Product Development Experts | CMC Pharma

What is CMC in pharmaceutical development?

CMC (Chemistry, Manufacturing, and Controls) is one of the most important activities in drug product development. It occurs during all stages of the drug development cycle and ensures quality and consistency during the manufacturing of the pharmaceutical product. CMC is a critical component of all pharmaceutical products that cannot be overlooked. In pharmaceuticals, CMC makes sure that every batch of medicine is made exactly the same way, whether it’s used in a clinical trial or sold commercially. It ensures that the drug remains stable over time, is manufactured with strict quality controls and passes all appropriate tests, and meets all safety requirements set by regulatory agencies like the FDA. Without meeting all CMC requirements, a drug couldn’t be approved or trusted for use to ensure safety and efficacy.

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Appropriate CMC rigor applies to all stages of pharmaceutical development and focuses on creating consistency in drug product stability, release, and manufacturing. The manufacture and testing of all pharmaceutical products must comply with FDA, ICH, and cGMP guidance and regulations. Without developing the appropriate CMC package, the product would be deemed unsafe and FDA approval would not be achieved.

Why Choose CMC Pharma for Chemistry, Manufacturing, and Controls?

There is a reason CMC is in our name: our main goal is to help develop new and better drug formulations, transforming innovative ideas into approved products. Our staff possesses decades of experience in formulation development and our bench scientists have extensive CMC experience in the development and manufacturing of traditional and complex dosage form drug products. We have prepared CMC sections for dozens of IND applications and are skilled in authoring and reviewing regulatory sections required to initiate human clinical trials.

While we don’t offer commercial-scale manufacturing capabilities, we provide all the development services to ensure your drug product meets all requirements for FDA approval. Our services include pre-formulation and formulation studies, development of analytical methods, ICH stability and compatibility studies at a wide range of conditions, and dosage form design. In addition, our pilot plant allows us to create prototypes of solid and liquid dosage forms, allowing the new formulations to be produced at a small scale to support clinical trials.

We Help Timelines

Many vertically integrated companies offer a full range of development and manufacturing capabilities but these large CDMOs will not put their total focus on your project. Instead, CMC Pharma focuses strictly on the formulation aspect of drug product development and helps keep your drug development program on track. We stay up to date on current FDA guidelines and regulatory requirements and are committed to supporting successful filings. Although we don’t manufacture commercial-scale drug products, we assist with tech transfer and are connected with manufacturing organizations around the world.

We thoroughly understand the complexities of regulatory filing for NDAs. Our extensive experience allows us to get your new drug approved as expeditiously as possible. When it comes to development in pharma, CMC and timelines are two of the most important things.

The use of medications, in combination with counseling and behavioral therapies, to provide a “whole-patient” approach to the treatment of substance use disorders. Medications used are approved by the Food and Drug Administration (FDA) and are clinically driven and tailored to meet each patient’s needs.

Research shows that a combination of medication and therapy can successfully treat substance use disorders, and for some medications can help sustain recovery. Medications are also used to prevent or reduce opioid overdose.

The ultimate goal is full recovery, including the ability to live a self-directed life. This treatment approach has been shown to:

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• Improve patient survival
• Increase retention in treatment
• Decrease illicit opiate use and other criminal activity among people with substance use disorders
• Increase patients’ ability to gain and maintain employment
• Improve birth outcomes among women who have substance use disorders and are pregnant

Research also shows that these medications and therapies can contribute to lowering a person’s risk of contracting HIV or hepatitis C by reducing the potential for relapse. Learn more about substance misuse and how it relates to HIV, AIDS, and Viral Hepatitis.

Medications for Substance Use Disorders

The FDA approved several medications to treat alcohol use disorders (AUD) and opioid use disorders (OUD). These medications relieve the withdrawal symptoms and psychological cravings that cause chemical imbalances in the body. Medications used are evidence-based treatment options and do not just substitute one drug for another.

Medications for Alcohol Use Disorder (MAUD)

Acamprosate, disulfiram, and naltrexone are the most common medications used to treat alcohol use disorder. They do not provide a cure for the disorder but are most effective for people who participate in a treatment program.

Medications for Opioid Use Disorder (MOUD)

Buprenorphine, methadone, and naltrexone are the most common medications used to treat opioid use disorder (OUD). These medications help normalize brain chemistry, block the euphoric effects of alcohol and opioids, relieve physiological cravings, and restore normal body functions without the harmful effects of the substances. They are effective in treating OUD related to short-acting opioids such as heroin, morphine, and codeine, as well as semi-synthetic opioids like oxycodone and hydrocodone. These medications are safe for long-term use—ranging from months to a lifetime—but consult your doctor before discontinuing them.

Child Safety

It’s important to remember that if medications are allowed to be kept at home, they must be locked in a safe place away from children. Methadone in its liquid form is colored and can be mistaken for a fruit juice. Children who mistakenly take medications may overdose or have an adverse reaction. Assistance needs to be sought for any known or suspected accidental ingestion.

Prevent children from accidentally taking medication by storing it out of reach. For more information, visit CDC’s Up and Away educational campaign. For information on how to dispose of medications in your house, refer to FDA’s information How to Safely Dispose of Unused or Expired Medicine or DEA’s drug disposal webpages.

Low Barrier Models of Care

Low barrier care is a model for treatment that reduces requirements and restrictions that may limit access to care and increases access to treatment for individuals with substance use disorders. This approach meets individuals where they are and helps provide culturally sensitive care tailored to the unique circumstances and challenges that each person faces, improving treatment engagement and outcomes.

Learn more from SAMHSA’s Advisory: Low Barrier Models of Care for Substance Use Disorders.

Patient Rights

SAMHSA produced a brochure designed to assist patients and to educate and inform others (PDF | 415 KB). Under the Confidentiality Regulation, 42 Code of Federal Regulations (CFR) 2, personally identifiable health information relating to substance use and alcohol treatment must be handled with a higher degree of confidentiality than other medical information.

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Related Resources

• Alcohol misuse and AUD
• Medication for the Treatment of Alcohol Use Disorder: A Brief Guide
• TIP 49: Incorporating Alcohol Pharmacotherapies Into Medical Practice
• TIP 63: Medications for Opioid Use Disorder