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Lithium carbonate manufacturer?

See the DrugPatentWatch profile for Lithium

Lithium carbonate is a prescription medication used mainly to stabilize mood in bipolar disorder and in some cases to treat other psychiatric or neurological conditions. Because it is a regulated drug, production is tightly controlled under Good Manufacturing Practice (GMP) and regulatory approvals (e.g., FDA in the U.S., EMA in Europe).

Below is a snapshot of the most prominent manufacturers that supply lithium carbonate in the U.S. and globally. These companies produce the drug in tablet or capsule form (most commonly 15 mg‑80 mg tablets) and supply both branded and generic products.

Manufacturer Brand / Generic name Typical dosage form Main markets Contact / Website
GlaxoSmithKline (GSK) Lithobid® 15 mg–80 mg tablets U.S., U.K., EU, Canada www.gsk.com
Pfizer Lithobid® (licensed from GSK in the U.S.) 15 mg–80 mg tablets U.S., U.K., EU www.pfizer.com
Viatris (formerly Mylan) Lithium carbonate (generic) 15 mg–80 mg tablets U.S., Canada, EU www.viatris.com
Teva Pharmaceuticals Lithium carbonate (generic) 15 mg–80 mg tablets U.S., Canada, EU www.tevapharm.com
Sandoz (Novartis) Lithium carbonate (generic) 15 mg–80 mg tablets U.S., Canada, EU www.sandoz.com
Bausch Health Lithium carbonate (generic) 15 mg–80 mg tablets U.S., Canada, EU www.bauschhealth.com
Mylan (now part of Viatris) Lithium carbonate (generic) 15 mg–80 mg tablets U.S., Canada, EU www.mylan.com
Sarepta Therapeutics Lithium carbonate (generic) 15 mg–80 mg tablets U.S., Canada www.sarepta.com
Hetero Drugs Lithium carbonate (generic) 15 mg–80 mg tablets U.S., Canada, EU www.hetero.com
Horizon Pharma Lithium carbonate (generic) 15 mg–80 mg tablets U.S., Canada, EU www.horizonpharma.com

Quick note:

  • In many countries, lithium carbonate is only available on prescription and the product must meet stringent safety and quality requirements.
  • The above list is not exhaustive; many other regional manufacturers produce the drug in smaller volumes.

Key points about the manufacturing process

Step What happens Why it matters
Raw material sourcing Lithium salt (often lithium chloride or lithium hydroxide) is purified. Guarantees elemental purity and prevents heavy‑metal contamination.
Chemical conversion Lithium chloride + sodium carbonate → lithium carbonate + sodium chloride; or lithium hydroxide + CO₂ → lithium carbonate. Produces the active pharmaceutical ingredient (API) with high crystalline quality.
Drying & milling API is dried and milled to a target particle size. Affects dissolution rate and tablet compression.
Tablet compression API mixed with excipients, compressed into tablets. Must meet tablet strength, uniformity, and disintegration specs.
Quality control Micro‑analysis, purity, assay, moisture, dissolution, stability testing. Ensures batch-to-batch consistency and patient safety.
GMP & regulatory compliance Facilities are GMP‑certified; batch records are audited. Required for FDA/EMA approval and for pharmacy dispensing.

Typical dosage forms & strengths

Strength Common use (approximate) Typical package size
15 mg Low‑dose prophylaxis (e.g., mild bipolar) 30 or 60 tablets
30 mg Moderate prophylaxis 30 or 60 tablets
45 mg Moderate‑to‑high prophylaxis 30 or 60 tablets
60 mg High‑dose prophylaxis 30 or 60 tablets
80 mg Maximal prophylaxis (rare) 30 or 60 tablets

The dose is usually titrated under a physician’s supervision based on serum lithium levels (typically 0.6–1.2 mEq/L) to avoid toxicity.

How to source lithium carbonate

  1. Verify the prescription requirement – In the U.S. and most other countries, lithium carbonate is a prescription drug.
  2. Choose a GMP‑certified supplier – Look for manufacturers that provide a Certificate of Analysis (CoA) for each batch.
  3. Request a product sheet – Includes dosage, formulation, stability data, and labeling.
  4. Confirm regulatory status – FDA‑approved (if in the U.S.) or EMA‑approved (if in Europe).
  5. Place an order – Usually through a licensed distributor or directly from the manufacturer’s sales portal.

Final reminder

While I’m happy to share manufacturer information, the actual procurement and use of lithium carbonate should always be overseen by a qualified healthcare professional or licensed pharmacist to ensure safe dosing



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