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Pregabalin is a potent anticonvulsant and neuropathic pain-relieving Active Pharmaceutical Ingredient (API), widely prescribed for conditions such as epilepsy, fibromyalgia, generalized anxiety disorder (GAD), and neuropathic pain associated with diabetes or spinal cord injury.
At Bluepill Express, we are a WHO-GMP, ISO, and cGMP-certified pharmaceutical API manufacturer and exporter, delivering high-purity Pregabalin that meets global pharmacopoeial standards (IP/BP/USP/EP).
Our Pregabalin API is produced under strict quality control protocols, ensuring optimum assay value, excellent flow properties, and consistent particle size distribution—ideal for both capsule and tablet formulations.
Bluepill Express serves clients across Africa, Asia, the Middle East, Latin America, CIS, and Europe, providing regulatory-compliant API documentation and custom bulk packaging for international shipment.
Therapeutic Category
- Anticonvulsant
- Neuropathic Pain Reliever
- Anxiolytic (Anti-Anxiety Agent)
- Antiepileptic Drug (AED)
Mechanism of Action
Pregabalin acts by binding to the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system.
This interaction reduces calcium influx into neurons, thereby decreasing the release of several neurotransmitters, including glutamate, norepinephrine, and substance P.
As a result, Pregabalin helps to stabilize neuronal activity, reduce seizure frequency, and alleviate neuropathic pain effectively.
Its dual role in nerve pain modulation and anxiety relief makes it one of the most versatile molecules in modern psychoneurological therapy.
Chemical Information
| Parameter | Details |
|---|---|
| Chemical Name | (S)-3-(Aminomethyl)-5-methylhexanoic acid |
| Molecular Formula | C8H17NO2 |
| Molecular Weight | 159.23 g/mol |
| CAS Number | 148553-50-8 |
| Therapeutic Class | Anticonvulsant / Neuropathic Pain Agent |
| Pharmacopoeial Compliance | IP / BP / USP / EP |
| Synonyms | (S)-Isobutyl GABA, Pregabalin API |
Physical & Chemical Properties
| Property | Specification |
|---|---|
| Appearance | White or off-white crystalline powder |
| Odor | Odorless |
| Taste | Slightly bitter |
| Solubility | Freely soluble in water; slightly soluble in ethanol and methanol |
| Melting Point | 194°C – 197°C |
| pH (1% solution) | 6.0 – 7.0 |
| Stability | Stable under recommended conditions |
| Storage | Store in tightly closed container below 25°C in a dry area |
Technical Specifications (Bluepill Express Standards)
| Parameter | Specification |
|---|---|
| Identification | IR and HPLC spectra match reference standard |
| Assay (Purity) | 98.0% – 102.0% (on anhydrous basis) |
| Specific Optical Rotation | +9.5° to +10.5° |
| Water Content | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Bulk Density | 0.35 – 0.55 g/ml |
| Particle Size | Customized to client requirement |
| Related Substances | ≤ 0.1% individual impurity |
| Total Impurities | ≤ 0.3% |
| Microbial Limits | Complies with pharmacopeial standards |
Pharmacological Applications
Pregabalin is indicated for the management of:
- Epilepsy (as adjunctive therapy for partial seizures)
- Neuropathic Pain associated with Diabetes Mellitus (Diabetic Neuropathy)
- Postherpetic Neuralgia (PHN)
- Fibromyalgia Syndrome
- Generalized Anxiety Disorder (GAD)
- Neuropathic Pain from Spinal Cord Injury
Pregabalin provides superior tolerability, rapid onset of action, and predictable pharmacokinetics, leading to consistent therapeutic outcomes.
Manufacturing & Quality Assurance
Our Pregabalin API manufacturing process is designed as per ICH Q7 and Q8 quality guidelines, focusing on:
- Advanced multi-step synthesis with enantiomeric purity control (>99%)
- Analytical verification using HPLC, FTIR, and NMR
- In-process QC monitoring for assay and impurity profile
- Stability testing as per ICH Q1A (R2) guidelines
- Nitrogen-flushed HDPE containers to prevent oxidation and moisture exposure
Each batch is accompanied by a Certificate of Analysis (COA) confirming compliance with pharmacopoeial standards.
Pharmacokinetics Overview
- Bioavailability: >90% after oral administration
- Peak Plasma Time (Tmax): 1 hour
- Elimination Half-life: 6 hours
- Metabolism: Minimal; excreted largely unchanged
- Excretion: Primarily via kidneys (~98%)
Pregabalin exhibits linear pharmacokinetics and no significant protein binding, ensuring consistent plasma concentration.
Dosage Forms Using Pregabalin API
- Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 300 mg
- Tablets: 50 mg, 75 mg, 150 mg, 300 mg
- Oral Solutions / Syrups: 20 mg/ml
Common brand equivalents include Lyrica®, Nervigesic®, and Neugaba®.
Packaging & Export Details
| Detail | Specification |
|---|---|
| Packaging Type | HDPE drums / fiber containers with double PE liners |
| Pack Sizes Available | 5 kg / 10 kg / 25 kg / 50 kg |
| Labeling | As per international export compliance standards |
| Shelf Life | 36 months when stored in recommended conditions |
| Supply Form | Crystalline Powder |
| Mode of Dispatch | Air / Sea freight in moisture-protected packaging |
| Export Destinations | Africa, Asia, Latin America, Middle East, CIS, and Europe |
Documentation Support Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data Sheet (ICH Q1A)
- Non-GMO and Allergen-Free Declaration
- Residual Solvent Declaration
- CTD / DMF Documentation (available upon request)
Safety & Handling
- Avoid inhalation, ingestion, or prolonged contact.
- Use gloves, protective goggles, and dust mask during handling.
- Wash hands thoroughly after use.
- Dispose of residual material per local environmental regulations.
Storage Recommendations
- Store below 25°C in dry, cool conditions.
- Keep away from direct sunlight and moisture.
- Ensure airtight packaging when not in use.
Regulatory Compliance
Bluepill Express ensures that Pregabalin API adheres to global regulatory and quality frameworks:
- WHO-GMP Certified Manufacturing Unit
- ISO 9001:2015 Quality Management System
- Conforms to IP, BP, USP, and EP standards
- BSE / TSE Free
- Non-GMO, Halal, and Kosher Compliant
- REACH Compliant for EU Exports
Composition
Active Ingredient: Pregabalin (C8H17NO2)
Form: Crystalline API powder
Purity: ≥99.5%
Global Market Applications
Pregabalin API by Bluepill Express is utilized by formulation manufacturers in:
- Antiepileptic Capsules / Tablets
- Neuropathic Pain Relief Combinations
- Anti-Anxiety Therapies
- Fibromyalgia Treatment Products
We are a trusted export partner to pharma manufacturers, contract formulators, and research organizations worldwide.
Why Choose Bluepill Express for Pregabalin API?
- WHO-GMP & ISO-certified global manufacturer
- Full documentation support for regulatory submissions
- Reliable batch consistency & controlled quality
- Worldwide export capability with flexible MOQ
- End-to-end logistics support including temperature-controlled shipping
