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China Top 10 Licensed Pregabalin Tablet Manufacturers

Pregabalin Tablets occupy a well-established place in the global prescription-medicine landscape, but choosing a manufacturer requires more than comparing price or production capacity. The World Health Organization’s ATC/DDD Index assigns pregabalin the code N03AX16, providing a consistent reference for identifying the medicine across drug information systems. A useful starting point.

Market context matters, too. IQVIA’s Global Use of Medicines 2024: Outlook to 2028 projects worldwide medicine spending will exceed US$2.3 trillion by 2028. This broad forecast is not specific to pregabalin, but it highlights why buyers need careful supplier checks as pharmaceutical markets expand. Scale alone proves little. Manufacturing-site authorization, current product registration, documented quality systems, and transparent inspection histories are more meaningful signals.

This guide examines ten Chinese manufacturers associated with licensed Pregabalin Tablets, using publicly verifiable company and regulatory information wherever available. The word “top” should be read as a practical comparison, not an official government ranking. Licensing and product registrations can vary by market and change over time; a company’s status should therefore be checked with the relevant regulator before procurement decisions. Public records can also be incomplete or difficult to compare. That limitation deserves attention. The aim here is a clear, evidence-led introduction to potential suppliers—not a guarantee of product quality, clinical suitability, or current authorization in every country.

China Top 10 Licensed Pregabalin Tablet Manufacturers
Table of Contents [Hide]
1 Pregabalin Profile: C₈H₁₇NO₂, 159.23 g/mol, and ATC Code N03AX16
2 Clinical and Product Benchmarks: >90% Oral Bioavailability and Linear Pharmacokinetics
3 China’s NMPA Licensing Framework: Approval Records, GMP Status, and Product Scope
4 Profiles of 10 Licensed Manufacturers: Approved Strengths, Dosage Forms, and Sites
5 Industry Comparison: Quality Certifications, Production Capacity, and Market Indicators

Pregabalin Profile: C₈H₁₇NO₂, 159.23 g/mol, and ATC Code N03AX16

Pregabalin has the molecular formula C₈H₁₇NO₂ and a molar mass of 159.23 g/mol. The formula represents eight carbon atoms, seventeen hydrogen atoms, one nitrogen atom, and two oxygen atoms in each molecule. Numbers matter. They help laboratories confirm identity and calculate quantities, but they do not describe a tablet’s full performance.

The ATC code N03AX16 places pregabalin among other antiepileptic medicines. The classification is a reference system, not a complete guide to an individual product’s approved uses. Those can vary by market and product information. For licensed tablet manufacturers, consistent identity, assay, dissolution, and stability testing matter alongside accurate labeling. A tablet may look uniform on a white inspection tray, yet appearance alone cannot confirm its strength or quality. Batch records and validated testing provide stronger evidence. A molecular profile is useful, but it is not the whole story; I should be careful not to mistake neat chemical figures for proof of manufacturing quality.

Pregabalin Molecular Profile

Pregabalin has the molecular formula C₈H₁₇NO₂ and a molecular weight of approximately 159.23 g/mol. The bars show each element’s calculated contribution to that molecular weight, based on standard atomic weights. Its ATC code is N03AX16.

Clinical and Product Benchmarks: >90% Oral Bioavailability and Linear Pharmacokinetics

Pregabalin tablets are assessed not only by strength and tablet appearance, but by how consistently they deliver medicine. A key clinical benchmark is oral bioavailability above 90%, with absorption that is generally predictable across usual doses. That matters. Clinicians can interpret dose changes more confidently when exposure rises in a roughly linear manner.

For manufacturers, these pharmacokinetic features make formulation control important. Each batch should meet defined limits for active ingredient content, tablet disintegration, dissolution, and stability. A tablet may look uniform on the production line, yet small differences in dissolution can affect quality. That detail deserves attention. Reliable product documentation should connect laboratory results with validated manufacturing controls, rather than relying on a single headline figure.

Pregabalin is cleared mainly through the kidneys, so patient factors can influence exposure even when the product performs as intended. Linear pharmacokinetics does not mean every patient responds identically, or that different products are automatically interchangeable. Responsible comparisons among licensed manufacturers should consider regulatory records, batch consistency, and evidence for the finished tablet. No benchmark tells the whole story. Independent testing and careful review remain useful, especially when public product data are incomplete.

China Top 10 Licensed Pregabalin Tablet Manufacturers - Clinical and Product Benchmarks: >90% Oral Bioavailability and Linear Pharmacokinetics

Scope note: This table presents ten general clinical and product benchmarks for pregabalin. It does not identify or rank manufacturers, confirm any company’s Chinese license, or provide manufacturer-specific test results. Authorization, dosage forms, strengths, and approved indications must be checked in the applicable official product records.

No. Benchmark Established reference Product assessment relevance
1 Oral bioavailability At least 90%; generally independent of dose. A key molecule-level pharmacokinetic property; it is not a substitute for product-specific quality or bioequivalence evidence.
2 Dose proportionality Plasma exposure (AUC and peak concentration) increases approximately in proportion to dose over the studied range. Supports predictable exposure changes when the dose is adjusted; clinical dosing still depends on indication and renal function.
3 Time to peak concentration Peak plasma concentration is typically reached about 1.5 hours after dosing in the fasted state. A pharmacokinetic reference value; actual product performance should be evaluated using its approved labeling and, where applicable, bioequivalence data.
4 Effect of food Food can lower peak concentration by approximately 25–30% and delay the peak to about 3 hours; overall exposure (AUC) is not materially affected. Useful context for interpreting administration instructions and food-effect information in product labeling.
5 Steady state Steady-state concentrations are generally reached within 24–48 hours with repeated dosing in people with normal renal function. A molecule-level reference; impaired renal function can change the time course and exposure.
6 Elimination half-life Mean half-life is approximately 6.3 hours in adults with normal renal function. Half-life may increase as renal function declines; it should not be used alone to determine an individual dose.
7 Metabolism Pregabalin undergoes little metabolism. The low extent of metabolism is a known pharmacological characteristic, not a manufacturer-specific differentiator.
8 Route of elimination Elimination is primarily renal, with most of the dose excreted unchanged in urine. Renal function is important to product labeling and clinical dose adjustment.
9 Plasma protein binding Pregabalin does not bind appreciably to plasma proteins. This is a molecule-level characteristic and does not establish the quality or interchangeability of a particular tablet.
10 Authorization and product verification Approved dosage forms, strengths, indications, and labeling can vary by jurisdiction and product. Verify each product’s current authorization and approved information in official Chinese regulatory records; do not infer licensing from general pregabalin benchmarks.

Reference note: Clinical pharmacokinetic values are general pregabalin reference-label information. They do not represent independent testing or claims about any specific manufacturer or product.

China’s NMPA Licensing Framework: Approval Records, GMP Status, and Product Scope

China’s Top 10 licensed pregabalin tablet manufacturers should be assessed through current regulatory records, not directory claims alone. The National Medical Products Administration (NMPA) database can help confirm product approvals and the responsible manufacturing entity. Check the registration details, dosage form, strength, and approval status. Small differences matter.

A tablet approval does not automatically establish that every site operated by a company makes that product. Compare the approved product information with the manufacturing address and relevant license scope. GMP status also needs context: review the applicable site, inspection information, and record date. A certificate or historical inspection entry is not, by itself, proof of current compliance. Records may lag. That detail is easy to miss.

For a useful top-ten comparison, document each manufacturer’s verified approval record and the exact product scope shown in official sources. Distinguish the marketing authorization holder from the actual production site where records allow. Then note when information was checked, since approvals and license details can change. Some public entries are difficult to interpret without careful cross-checking. A transparent table should flag unclear fields rather than quietly treating them as confirmed.

Profiles of 10 Licensed Manufacturers: Approved Strengths, Dosage Forms, and Sites

A useful profile of ten licensed pregabalin manufacturers should separate marketing authorization from actual production. Approval is country-specific, and the authorization holder may not operate the manufacturing site. For each company, record the registered strengths, dosage form, authorization status, and named production site, then verify these details against the relevant national medicines register. Small differences matter: a capsule is not a tablet, and an approved strength in one market does not establish approval elsewhere.

Regulatory labels provide a practical cross-check. U.S. FDA-approved pregabalin labeling lists capsules in eight strengths, from 25 mg to 300 mg, and an oral solution at 20 mg/mL. These are reference points, not a universal product list; tablet availability and approved strengths must be checked market by market. IQVIA Institute’s Global Use of Medicines 2024 outlook projected global medicine spending could approach US$2.3 trillion by 2028, underscoring the scale of medicine supply—but it does not verify individual pregabalin registrations. A careful manufacturer profile should therefore cite product-register entries and site records directly. The paperwork can be untidy; that is exactly where a second check helps.

Industry Comparison: Quality Certifications, Production Capacity, and Market Indicators

China’s licensed pregabalin tablet manufacturers are best compared through verifiable records, not promotional rankings. Check current manufacturing licences and publicly available GMP inspection or certification information. Confirm that documents match the specific production site and tablet dosage form. A certificate alone does not show how consistently a line performs.

Production capacity needs context. Compare stated annual output with actual utilization, number of tablet lines, and recent supply records where available. Market indicators may include product registrations, supply continuity, and publicly reported exports. These figures can be incomplete or measured differently, so avoid treating a large capacity figure as proof of dependable delivery. Numbers need context. A tidy comparison table can still hide gaps in the underlying data.

Tips: Ask for dated documents and site-specific evidence. Compare like with like: same dosage form, reporting period, and capacity unit. Note missing information rather than filling gaps with assumptions. One detail is easy to overlook: a manufacturer’s published capacity may describe several products, not pregabalin tablets alone.

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