Lamotrigine

Lamotrigine
Product Description

Lamotrigine is an anti-epileptic medication, also called an anticonvulsant. Lamotrigine is used alone or with other medications to treat epileptic seizures in adults and children. Lamotrigine is also used to delay mood episodes in adults with bipolar disorder (manic depression). Immediate-release lamotrigine can be used in children as young as 2 years old when it is given as part of a combination of seizure medications. However, this form should not be used as a single medication in a child or teenager who is younger than 16 years old. Extended-release lamotrigine is for use only in adults and children who are at least 13 years old. Lamotrigine may also be used for purposes not listed in this medication guide.

Polpharma S.A.

  • PL
  • 2015
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Service
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Pharmaceutical company
Specifications
  • CAS Registry Number
    84057-84-1
  • Details
    Status Commercial


    Therapeutic cat. Neurology


    Polymorphic form


    Anhydrous monoclinic


    CAS No.84057-84-1


    EU DMF readiness


    CEP


    CHINESE  DMF


    JAPANESE DMF


    KOREAN  DMF


    US DMF readiness
  • Selling Points
    ✔️ HP API (OEL up to 10 ng/m3)
    ✔️ EU manufacturing site
    ✔️ US FDA-approved
    ✔️ 70 years of experience in small molecules
    ✔️ cGMP manufacturing
    ✔️ Highest quality standards
    ✔️ Research, Development, and Commercial Manufacturing
    ✔️ World-class regulatory support
    ✔️ Smooth and transparent cooperation

Polpharma S.A.

  • PL
  • 2015
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Service
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Pharmaceutical company

More Products from Polpharma S.A. (40)

  • Isavuconazole sulfate

    Product Isavuconazole sulfate

    Isavuconazonium is used to treat infections caused by certain types of fungus (aspergillosis or mucormycosis).Isavuconazonium may also be used for purposes not listed in this medication guide.

    Polpharma API • Innovative manufacturing process • Chemical purity above 99,5%
  • Abemaciclib

    Product Abemaciclib

    Polpharma API • OEB 4 • Under development
  • Aniracetam

    Product Aniracetam

    Aniracetam is a cognitive enhancer employed to improve memory and attention issues associated with cerebrovascular conditions and degenerative brain diseases.
  • Brexpiprazole

    Product Brexpiprazole

    Polpharma API

    Drug descriptionBrexpiprazole is an antipsychotic medication that is used to treat the symptoms of schizophrenia. It is also used together with other medications to treat major depressive disorder in adults. Brexpiprazole may also be used for purposes not listed in this...
  • Gilteritinib fumarate

    Product Gilteritinib fumarate

    Gilteritinib is an AXL receptor tyrosine kinase inhibitor used to treat relapsed or refractory acute myeloid leukemia.

  • Ibandronate sodium

    Product Ibandronate sodium

    Ibandronate is a bisphosphonate medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures. Ibandronate is used to treat or prevent osteoporosis in women after menopause. Ibandronate may also be used for purposes not listed in this med...
  • Opipramol dihydrochloride

    Product Opipramol dihydrochloride

    Opipramol is a medication used to treat generalized anxiety and somatoform disorders.

  • Risedronate sodium 2.5-hydrate

    Product Risedronate sodium 2.5-hydrate

    Risedronate is used to treat osteoporosis caused by menopause, or steroid use. risedronate is for use when you have a high risk of bone fracture due to osteoporosis. Risedronate is also used to treat Paget's disease of bone. Risedronate may also be used for purposes not listed in this medication ...
  • Sacubitril Valsartan

    Product Sacubitril Valsartan

    Crystalline polymorphic form
    Sacubitril/valsartan is the first agent to be approved in a new class of drugs called angiotensin receptor neprilysin inhibitor (ARNI). The medication is FDA-approved to treat patients with chronic heart failure with reduced ejection fraction (HFrEF) with NYHA class I...
  • Sildenafil citrate

    Product Sildenafil citrate

    Sildenafil relaxes muscles of the blood vessels and increases blood flow to particular areas of the body. Sildenafil under the name Viagra is used to treat erectile dysfunction (impotence) in men. Another brand of sildenafil is Revatio, which is used to treat pulmonary arterial hypertension and i...
  • Tolterodine tartrate

    Product Tolterodine tartrate

    Tolterodine is used in adults to treat overactive bladder with symptoms of urinary frequency, urgency, and incontinence (urine leakage).

  • Vardenafil hydrochloride

    Product Vardenafil hydrochloride

    Vardenafil is an oral therapy for erectile dysfunction that selectively inhibits cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). During sexual stimulation, nitric oxide (NO) is released from nerve endings and endothelial cells in the corpus cavernosum, which activa...

Polpharma S.A. resources (5)

  • News CPHI Barcelona 2023: Tackling the Pharma Talent Precipice – Part 2

    This year at CPHI Barcelona (24–26 October, 2023) we sat down with C-suite executives and HR professionals to discuss the looming talent crisis in the pharmaceutical industry. With hybrid working persisting post-pandemic and a growing skills gap, how can the pharmaceutical supply chain adjust to a changing labour force? 
  • Brochure API Product List 2025

    Thanks to over 70 years of experience in process development, scale-up and cGMP manufacturing, we support both emerging and established pharmaceutical customers in the development and commercialization of their small molecule API clinical candidates. At our FDA-approved plant located in Central Europe, we provide end-to-end solutions from API development to scale-up allowing smooth process transfer for commercial-scale manufacturing capabilities, with world-class regulatory support. Our strong R&D management team, experienced in the development of chemical processes and complex projects, provides a wide range of solutions to our customers, applying a variety of chemical reactions and conditions, including cryogenic, High Pressure, strong base reactions, and tailor-made particle size distribution modifications. At Polpharma quality comes first. Regular FDA audits prove our reliability and credibility towards business partners around the world.
  • News KiloLab Laboratory: strategic milestone achieved!

    KiloLab Laboratory – a development and production in a kilogram scale – has been launched, according to Polpharma API development strategy adopted in 2021.
  • Brochure Polpharma API CDMO offer

    Thanks to over 70 years of experience in process development, scale-up and cGMP manufacturing, we support both emerging and established pharmaceutical customers in the development and commercialization of their small molecule API clinical candidates. At our FDA-approved plant located in Central Europe, we provide end-to-end solutions from API development to scale-up allowing smooth process transfer for commercial-scale manufacturing capabilities, with world-class regulatory support. Our strong R&D management team, experienced in the development of chemical processes and complex projects, provides a wide range of solutions to our customers, applying a variety of chemical reactions and conditions, including cryogenic, High Pressure, strong base reactions, and tailor-made particle size distribution modifications. At Polpharma quality comes first. Regular FDA audits prove our reliability and credibility towards business partners around the world.
  • Video Strategic investment HP API facility

    As an EU-based Contract Development and Manufacturing Organization (CDMO) and supplier of active pharmaceutical ingredients, we are advancing our technology capabilities with an Occupational Exposure Limit (OEL) as low as 10 ng/m³ (OEB 6).
    Our new capabilities enable GMP and FDA-approved kilo-scale production, offering batch sizes of up to 1.5 kg. This facility features dedicated Analytical Development Laboratories (ADL) and Process Development Laboratories (PDL) to ensure comprehensive support for all production phases. The design incorporates state-of-the-art isolator technology to ensure the safety of both personnel and products, along with industry-standard secondary containment solutions integrated into the infrastructure.
    We have secured future capacity expansion through both internal enhancements and external partnerships, with the goal of doubling our production capacity.