Pregabalin API Manufacturer & Supplier India
GMP-Certified · API Exporter India · Surat, Gujarat
Anticonvulsant and neuropathic pain API used in epilepsy, generalized anxiety disorder, and neuropathic pain. Request a quotation for bulk Pregabalin supply to regulated global markets.
Pregabalin Product Overview
Welcome to Vubrix Pharma, your trusted global partner for high-quality Pregabalin Active Pharmaceutical Ingredient (API) and finished dosage forms. With state-of-the-art manufacturing facilities in India, we supply pharmaceutical companies, importers, and distributors across the globe with Pregabalin that meets strict IP, BP, and USP pharmacopeial standards.
Pregabalin (CAS No: 148553-50-8) is a synthetic analog of the neurotransmitter gamma-aminobutyric acid (GABA). It is a highly effective anticonvulsant and analgesic medication.
Chemical Name: (S)-3-(Aminomethyl)-5-methylhexanoic acid. Appearance: White to off-white crystalline powder. Molecular Formula: C8H17NO2. Molecular Weight: 159.23 g/mol. Solubility: Sparingly soluble in water, soluble in basic and acidic aqueous solutions.
Applications
- Neuropathic Pain: Highly effective in treating pain associated with diabetic peripheral neuropathy and postherpetic neuralgia.
- Fibromyalgia: A primary treatment option for managing widespread muscle pain and tenderness.
- Epilepsy: Used as an adjunctive therapy for adults with partial onset seizures.
- Generalized Anxiety Disorder (GAD): Approved in Europe and other regions for the treatment of GAD.
Technical Specifications
- Purity: NLT 99.5% (by HPLC)
- Impurity Profile: Strictly controlled within ICH guidelines.
- Documentation: Certificate of Analysis (CoA), MSDS, MOA, and DMF (Drug Master File) available upon request.
Manufacturing Process
Mechanism of Action: Pregabalin binds with high affinity to the alpha-2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. This binding reduces the calcium-dependent release of pro-nociceptive neurotransmitters, including glutamate, norepinephrine, and substance P, thereby exerting its analgesic and anticonvulsant effects.
At Vubrix Pharma, quality is non-negotiable. Our Pregabalin API is synthesized in a WHO-GMP and ISO-certified facility utilizing advanced crystallization techniques to ensure perfect particle size distribution.
Learn more about our manufacturing capabilities and quality assurance systems.
Packaging Information
Standard Packaging: 25 Kg double HM-HDPE bags packed in robust fiber drums, ensuring protection from moisture and transit damage. Custom packaging available for bulk orders.
Storage Information
Storage Conditions: Store in a cool, dry, and well-ventilated area away from direct sunlight and incompatible materials.
Quality Standards
Our manufacturing processes adhere to the strictest global regulatory standards. We guarantee rigorous impurity profiling, residual solvent monitoring (ICH Q3C), and full traceability for every batch produced.
Export Markets
Vubrix Pharma is a premier exporter serving over 40 countries, including the USA, UK, Germany, UAE, and Brazil. Our logistics team ensures regulatory compliance, seamless customs clearance, and timely delivery for all international bulk shipments.
Why Choose Vubrix Pharma
Pharmaceutical Formulation Companies, Contract Manufacturing Organizations (CMOs), Medical Research Institutions, and Global Healthcare Distributors trust Vubrix Pharma for unparalleled quality, transparent DMF documentation, and reliable global supply chain management.
- Therapeutic class: Anticonvulsant
- End application: Neuropathic pain and anxiety formulations
Frequently Asked Questions about Pregabalin
What is Pregabalin API used for?
Pregabalin API is the active ingredient used to manufacture medications for neuropathic pain, epilepsy, fibromyalgia, and generalized anxiety disorder.
What pharmacopeial standards does Vubrix Pharma's Pregabalin meet?
Our Pregabalin meets IP (Indian Pharmacopoeia), BP (British Pharmacopoeia), and USP (United States Pharmacopeia) standards.
Is Vubrix Pharma a WHO-GMP certified manufacturer?
Yes, our manufacturing facility is WHO-GMP certified, ensuring global quality standards.
What is the CAS number for Pregabalin?
The CAS number for Pregabalin is 148553-50-8.
Do you provide a Drug Master File (DMF) for Pregabalin?
Yes, Open part DMF is available for regulatory submissions for qualified B2B buyers.
What is the minimum order quantity (MOQ) for bulk Pregabalin?
Our standard MOQ is 25 kg, but we can accommodate specific pilot batch requests.
How is the Pregabalin powder packaged for international shipping?
It is packed in double HM-HDPE bags enclosed in durable 25 kg fiber drums.
What is the purity level of your Pregabalin API?
We guarantee a purity level of Not Less Than (NLT) 99.5% as determined by HPLC.
Do you export Pregabalin to Europe and the USA?
Yes, we actively export to North America, Europe, the Middle East, Latin America, and Asia.
Can Vubrix Pharma manufacture finished Pregabalin capsules?
Yes, alongside API, we offer contract manufacturing for finished Pregabalin formulations.
What is the lead time for bulk orders?
Typical lead time is 2-4 weeks depending on the order volume and destination.
Are residual solvents controlled in your manufacturing process?
Absolutely. All residual solvents are strictly monitored and kept well below ICH Q3C limits.
Do you supply Pregabalin for veterinary use?
Yes, we can supply veterinary-grade API upon request.
How do you ensure the stability of the API during transit?
Our specialized packaging and temperature-controlled logistics partners ensure product stability.
Can I get a sample of Pregabalin API for testing?
Yes, commercial samples along with CoA can be provided to verified pharmaceutical companies.
What payment terms do you offer for international buyers?
We offer standard international trade terms including TT, LC at sight, depending on the client profile.
Is Pregabalin a controlled substance?
Classification varies by country (e.g., it is a Schedule V controlled substance in the USA). Buyers must ensure they have the necessary import licenses.
How does Pregabalin differ from Gabapentin?
While both act on calcium channels, Pregabalin generally has higher bioavailability and faster onset of action.
Can you handle custom particle size requirements?
Yes, our micronization facilities can tailor particle size distribution (PSD) to your formulation needs.
Who do I contact to initiate an order?
You can use the inquiry form on this page or contact our export sales team directly via email or WhatsApp.
Request a Quote for Pregabalin
Get pricing, MOQ, lead time, and documentation for Pregabalin. Our team responds within 24 hours.