Product Name: Pregabalin
Synonyms: (3S)-3-(Aminomethyl)-5-methylhexanoic acid
CAS No: 148553-50-8
Chemical Formula: C₈H₁₇NO₂
Grade: IP/USP
Appearance: White to off-white crystalline powder
Molar Mass: 159.23 g/mol
Solubility: Insoluble in water but is freely soluble in polar organic solvents such as methanol and acetonitrile.

Description

Chemignition is a leading manufacturer and exporter of Pregabalin Active Pharmaceutical Ingredients (API) worldwide. The company adheres to strict Quality Management Systems (QMS) to ensure compliance with Good Manufacturing Practices (cGMPs). This commitment to quality and regulatory standards guarantees that Chemignition produces Pregabalin of the highest quality and efficacy.

Pregabalin treats pain caused by conditions such as diabetes, painful rashes, and spinal cord injuries. It adjusts nerve cell activity in the human body and stabilizes mood swings.

During the manufacturing of Active Pharmaceutical Ingredients (API) and specialty chemicals, Chemignition employs various processes, including dissolution, charcoalization, filtration, leaching, extraction, crystallization, and purification.

Manufacturers commonly use Pregabalin API to produce pharmaceutical products, including tablets and capsules.

The U.S. Food and Drug Administration (FDA) approved Pregabalin in 2004 under the brand name Lyrica. It initially received approval for treating neuropathic pain associated with diabetic peripheral neuropathy and post-herpetic neuralgia. Subsequently, its indications expanded to include the management of fibromyalgia and as an adjunctive therapy for adults with partial onset seizures.

Storage Condition: Pack Pregabalin in a tightly closed double polythene bag within an HDPE or fiberboard container and store it at a temperature between 20°C and 25°C.

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