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Country of origin : Malta

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pregabalin

Tablets, extended release (ER) 82.5 mg, 165 mg, 330 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Unavailable markets
Vietnam
Comments
EU MA's Running
Manufacturer #21467
This global pharmaceutical company is dedicated to improving patients' lives through high-quality, differentiated products and services. They leverage a collaborative network to achieve success in key regions like the EU and North America. Their focus areas include women's health, infectious diseases, and potentially other therapeutic areas based on their recent approvals and launches. They produce prescription medications (including injectables) and tablets, demonstrating expertise in various dosage forms. The company holds GMP certifications and boasts successful product patents, solidifying its commitment to quality and innovation.

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Pregabalin manufacturers

What is Pregabalin?

Pregabalin is a drug that is used to treat various conditions such as epilepsy, generalized anxiety disorder, neuropathic pain, and fibromyalgia. It works by binding to a specific type of calcium channel in the nervous system, which helps decrease the release of certain neurotransmitters involved in pain and anxiety.

Pregabalin is sold under the brand name Lyrica. It is available in capsule or oral solution form. It is classified as an anticonvulsant or antiepileptic drug but is also used for other conditions due to its ability to modulate the activity of certain neurotransmitters in the brain.

While Pregabalin is generally considered safe and effective when prescribed, it can cause some side effects such as dizziness, drowsiness, weight gain, and dry mouth.

How does Pregabalin work?

Pregabalin works by binding to a specific type of voltage-gated calcium channels in the nervous system, which are found in neurons in the brain, spinal cord, and peripheral nervous system. Specifically, Pregabalin binds to the α2δ subunit of these channels, which reduces the influx of calcium ions into the neurons.

By reducing the influx of calcium ions, Pregabalin reduces the release of certain neurotransmitters such as glutamate, substance P, and norepinephrine. These neurotransmitters are involved in the transmission of pain signals and the development of anxiety.

Pregabalin's mechanism of action is complex and not fully understood, but it is believed to have an inhibitory effect on the release of certain neurotransmitters in the nervous system. By modulating the activity of these neurotransmitters, Pregabalin can help to alleviate pain, reduce anxiety, and prevent seizures.

Pregabalin is classified as an anticonvulsant or antiepileptic drug but is also used to treat other conditions such as neuropathic pain, fibromyalgia, and generalized anxiety disorder due to its ability to modulate the activity of specific neurotransmitters in the brain.

Pregabalin forms and dosage

Pregabalin is available in capsule or oral solution form. The capsules come in various strengths, typically ranging from 25 mg to 300 mg, while the oral solution comes in a concentration of 20 mg/mL.

The appropriate dosage of Pregabalin will depend on the condition being treated, the patient's age and weight, and other factors. The starting dose is usually low and gradually increases over time to achieve the desired therapeutic effect.

To treat neuropathic pain, the typical starting dose is 50 mg three times daily, which may be increased up to the highest dose of 300 mg daily. For the treatment of fibromyalgia, the typical starting dose is 75 mg twice daily, which may be increased up to the highest dose of 450 mg per day. For the treatment of generalized anxiety disorder, the typical starting dose is 75 mg per day, which may be increased to a maximum dose of 300 mg per day.

Abruptly stopping Pregabalin can cause withdrawal symptoms, so it is important to gradually reduce the dose under the supervision of a healthcare professional.

Pregabalin patent information

The compound Pregabalin was first invented and patented by Richard Bruce Silverman and his team at Northwestern University. The patent was filed in 1990 and issued in 1994 under US Patent No. 5,563,175. The rights to manufacture and market Pregabalin were initially licensed to Parke-Davis, a subsidiary of Pfizer. Parke-Davis later merged with Warner-Lambert, which Pfizer acquired in 2000.

Pfizer obtained additional patents for Pregabalin in various countries, which extended the exclusivity period for the drug. For example, the last patent expired in the United States in July 2019.

Pregabalin is now off-patent and available as a generic medication. Regulatory agencies have approved generic versions of Pregabalin in various countries, including the FDA in the United States.

Pregabalin manufacturers and brand names

Pregabalin is available under various brand names and is manufactured by several companies worldwide. Some of the commonly available brand names of Pregabalin include:

  • Lyrica (Pfizer)
  • Prebel (Intas Pharmaceuticals)
  • Pregabid (Sun Pharmaceutical Industries)
  • Pregacon (Glenmark Pharmaceuticals)
  • Pregalin (Macleods Pharmaceuticals)
  • Neurolin (Lupin Pharmaceuticals)
  • Nupentin (Cipla)

In addition to these brand names, Pregabalin is also available as a generic medication manufactured by several pharmaceutical companies worldwide. Some of the well-known generic manufacturers of Pregabalin include Teva Pharmaceuticals, Mylan, Aurobindo Pharma, and Dr. Reddy's Laboratories.

Pregabalin wholesale price

Here are some approximate wholesale prices of Pregabalin in the United States:

  • 25 mg capsule: $0.75 to $0.85 per capsule
  • 50 mg capsule: $1.00 to $1.20 per capsule
  • 75 mg capsule: $1.25 to $1.45 per capsule
  • 100 mg capsule: $1.50 to $1.70 per capsule
  • 150 mg capsule: $2.25 to $2.50 per capsule
  • 200 mg capsule: $2.75 to $3.00 per capsule
  • 225 mg capsule: $3.25 to $3.50 per capsule
  • 300 mg capsule: $3.75 to $4.00 per capsule

These prices are based on information from various sources and may not be exact for every situation. It is essential to check with specific wholesalers or distributors for accurate pricing information.

Connecting with Pregabalin manufacturers and suppliers

Pipelinepharma is a platform that provides services to pharmaceutical wholesalers, distributors, and manufacturers, helping them to find reliable suppliers and buyers for their products. If you are looking for Pregabalin manufacturers worldwide, Pipelinepharma can assist you in the following ways:

  1. Search for manufacturers: Pipelinepharma has a database of pharmaceutical manufacturers worldwide. By using its search function, you can search for Pregabalin manufacturers by location, product category, and other criteria.
  2. Contact manufacturers: Once you have identified potential manufacturers, Pipelinepharma can help you connect with them. 
  3. Get quotes: You can request a quote for the quantity of Pregabalin you need when submitting an inquiry online.
  4. Negotiate terms: Pipelinepharma can also assist you in negotiating the terms of the purchase, including the price, delivery schedule, and payment terms.

Pipelinepharma can be a valuable resource for those seeking reliable Pregabalin manufacturers worldwide. Its platform provides a simple and efficient way to search for and contact potential suppliers, and its team can assist with the negotiation and purchasing process.

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