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What is Cholecalciferol 60000 IU granules used for?

In the pharmaceutical industry, Cholecalciferol (Vitamin D3) 60,000 IU granules represent a high-potency “mega-dose” formulation. As a pharmacist, I characterize this product as a therapeutic loading dose rather than a daily supplement. It is specifically designed to rapidly correct clinical vitamin D deficiency and replenish depleted hepatic and adipose stores.

Primary Clinical Uses

  • Treatment of Vitamin D Deficiency: Specifically for patients with serum 25-hydroxyvitamin D [25(OH)D] levels significantly below 20 ng/mL.

  • Osteoporosis Management: Used as an intensive adjunct to primary osteoporosis therapies (like Bisphosphonates) to ensure adequate calcium absorption and bone mineralization.

  • Osteomalacia & Rickets: Essential for reversing the softening of bones in adults (osteomalacia) and correcting skeletal deformities in children (rickets).

  • Malabsorption Syndromes: Frequently prescribed for patients with conditions like Celiac disease, Crohn’s disease, or post-bariatric surgery, where standard daily doses are insufficient due to poor intestinal absorption.

  • Hypoparathyroidism: Used to maintain calcium homeostasis when parathyroid hormone function is compromised.

Mechanism of Action

Cholecalciferol is a fat-soluble vitamin that acts more like a pro-hormone. Once ingested:

  1. Hydroboxylation: It undergoes two hydroxylation steps—first in the liver to form 25(OH)D (Calcifediol) and then in the kidneys to form 1,25$(OH)_2$D (Calcitriol), the biologically active form.

  2. Target Action: Calcitriol binds to Vitamin D Receptors (VDR) in the intestines to stimulate the synthesis of calbindin, a protein that actively transports calcium across the intestinal mucosa into the bloodstream.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, 60,000 IU granules are a high-value niche product:

  • Granulation Technology: As a WHO-GMP manufacturer, we utilize fluid-bed processing to create free-flowing granules. The Vitamin D3 is often “beadletted” or micro-encapsulated to protect it from oxidation and light, which are the primary causes of degradation.

  • Sachet Packaging: Granules are typically packed in 1g or 2g triple-laminated sachets (Polyester/Alu/Poly) to provide a complete barrier against moisture and oxygen, ensuring a stable 24-month shelf life even in Zone IVb climates.

  • Dosing Schedule: Unlike daily tablets, these granules are usually administered once weekly or once monthly, which significantly improves patient compliance for chronic bone-health management.

  • Global Export Profile: Operating from Mumbai, we provide the CTD/eCTD Dossiers and stability data required for international registration. This high-strength formulation is a staple for B2B distributors in regions with limited sunlight or high rates of nutritional deficiency.

Cholecalciferol Granules Sachet

 

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What is CPM Chlorpheniramine Maleate used for?

In the pharmaceutical industry, Chlorpheniramine Maleate (CPM), typically manufactured in 4 mg tablets or as a syrup (2 mg/5 ml), is a classic first-generation H1-receptor antagonist of the alkylamine class. As a pharmacist, I characterize CPM as a versatile, high-potency antihistamine that is particularly valued for its rapid onset and its role as a “gold standard” ingredient in multi-action cold and flu formulations.

Primary Clinical Uses

  • Allergic Rhinitis: Effective relief from seasonal and perennial allergies, including sneezing, runny nose, and itchy/watery eyes.

  • Urticaria and Angioedema: Used to manage skin allergies, hives, and localized swelling.

  • Common Cold Symptoms: Frequently combined with decongestants and antipyretics (like Paracetamol) to reduce nasal secretions and “drying up” a runny nose.

  • Allergic Conjunctivitis: Relief of ocular itching and redness.

  • Anaphylactic Reactions: Used as adjunctive therapy (after Epinephrine) to control secondary allergic symptoms.

Mechanism of Action

CPM works by competitively blocking the H1-receptor sites on effector cells. By preventing histamine from binding to these receptors, it inhibits:

  1. Vascular permeability: Reducing swelling and fluid leakage.

  2. Smooth muscle contraction: Relieving respiratory and gastrointestinal constriction.

  3. Sensory nerve stimulation: Eliminating the “itch” sensation.

Unlike second-generation antihistamines (like Cetirizine), CPM readily crosses the Blood-Brain Barrier, which accounts for its significant sedative effect. This “side effect” is often utilized clinically to help patients sleep when allergy symptoms are severe.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, CPM is a core essential for any pharmaceutical portfolio:

  • API Versatility: CPM is a highly stable salt. As a WHO-GMP manufacturer, we utilize it in various dosage forms, from standalone 4 mg tablets to complex multi-ingredient “Cold & Flu” syrups and tablets.

  • Dose Precision: Because CPM is potent at low doses, we ensure absolute content uniformity through validated micro-blending techniques during the granulation process.

  • Global Export Stability: CPM is remarkably robust. We utilize PVC/PVDC or Alu-Alu blister packaging to guarantee a 36-month shelf life, even in the most challenging Zone IVb (hot and humid) environments across Africa and Southeast Asia.

  • B2B & Tender Supply: CPM is a high-volume “Essential Medicine.” Our Mumbai-based facility provides full CTD/eCTD Dossier support, making it a staple for government tenders and international B2B distributors.

Chlorpheniramine Tablets

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What is Chloroquine Phosphate 250mg used for?

In the pharmaceutical industry, Chloroquine Phosphate 250 mg (equivalent to 150 mg of Chloroquine base) is a 4-aminoquinoline derivative that has served as a foundational antimalarial and amebicidal agent for decades. As a pharmacist, I characterize Chloroquine as a high-volume essential medicine that remains a first-line choice in regions where parasite sensitivity is still maintained.

Primary Clinical Uses

  • Prophylaxis and Treatment of Malaria: Indicated for the prevention and treatment of acute attacks of malaria caused by Plasmodium vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum.

  • Extra-intestinal Amebiasis: Specifically used to treat amebic liver abscesses caused by Entamoeba histolytica when other treatments are not suitable.

  • Autoimmune Disorders: Frequently used off-label or as a secondary therapy for Rheumatoid Arthritis and Systemic Lupus Erythematosus (SLE) due to its mild immunosuppressive and anti-inflammatory properties.

Mechanism of Action

Chloroquine acts as a blood schizontocide. It enters the malaria parasite’s acidic food vacuole and inhibits the enzyme heme polymerase.

Normally, the parasite digests host hemoglobin and releases toxic free heme, which it then detoxifies into non-toxic hemozoin (malaria pigment). Chloroquine prevents this detoxification; the resulting accumulation of free heme is highly toxic, leading to the rapid lysis and death of the parasite.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Chloroquine Phosphate is a staple of high-capacity production:

  • API Purity & Standardization: As a WHO-GMP manufacturer, we ensure the API meets BP/USP/IP monographs, specifically monitoring for related substances and heavy metals to ensure long-term safety in chronic users.

  • Stability for Global Trade: Chloroquine is a robust molecule. We utilize PVC/PVDC or Alu-Alu blister packaging to ensure a stable 36-month shelf life, facilitating bulk exports to Zone IVb climates (Africa, SE Asia).

  • Volume and Tender Supply: Due to its cost-effective profile, Chloroquine 250 mg is a high-volume item for government health tenders and B2B distributors. Our Mumbai-based facility is optimized for the scale required for these large-scale international contracts.

  • Dossier Support: We provide comprehensive CTD/eCTD Dossiers to assist international partners in the registration process, ensuring compliance with global regulatory standards.

Chloroquine Phosphate Tablets

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What is Cetirizine 10mg used for?

In the pharmaceutical industry, Cetirizine Hydrochloride 10 mg is a potent, second-generation receptor antagonist. As a pharmacist, I classify Cetirizine as a “non-sedating” antihistamine—though technically, it is “low-sedating” compared to first-generation drugs. Its primary value in a product portfolio lies in its rapid onset of action and its high selectivity for peripheral histamine receptors.

Primary Clinical Uses

  • Allergic Rhinitis: Effectively relieves symptoms of hay fever and seasonal allergies, including sneezing, rhinorrhea (runny nose), and post-nasal drip.

  • Chronic Urticaria (Hives): It is a frontline treatment for chronic idiopathic urticaria, reducing the number, size, and itching of wheals.

  • Allergic Conjunctivitis: Manages ocular symptoms such as redness, itching, and watering of the eyes caused by environmental allergens.

  • Dermatological Allergies: Often used as an adjunct to treat pruritus (itching) associated with insect bites or contact dermatitis.

Mechanism of Action

Cetirizine works by selectively inhibiting peripheral $H_1$ receptors. When an allergen enters the body, mast cells release histamine, which binds to $H_1$ receptors and causes vasodilation, increased capillary permeability, and itching.

Cetirizine competes with free histamine for binding sites on these receptors. Unlike first-generation antihistamines (like Chlorpheniramine), Cetirizine has poor penetration across the Blood-Brain Barrier (BBB), which is why it causes significantly less drowsiness while maintaining high peripheral efficacy.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Cetirizine is a high-volume OTC and prescription staple:

  • API Purity & Stability: As a WHO-GMP manufacturer, we ensure the Cetirizine HCl API meets stringent BP/USP/IP monographs, specifically monitoring for the “Related Substance A” impurity to ensure safety and shelf-life.

  • Formulation Versatility: We manufacture Cetirizine in various formats, including film-coated tablets, chewable tablets for pediatrics, and oral syrups. For the 10 mg tablets, we focus on a small, easy-to-swallow “breakline” design.

  • Packaging for Global Markets: To protect against the hygroscopic nature of the salt, we utilize PVC/PVDC or Alu-Alu blister packaging. This ensures the product remains stable for 24–36 months in Zone IVb (hot and humid) climates.

  • B2B & Tender Supply: Cetirizine is a core item for international B2B distributors. Our Mumbai-based facility provides complete CTD/eCTD Dossiers for rapid registration in global markets.

Cetrizine Tablets

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Is Carvedilol a High Risk Medication?

In the pharmaceutical industry, Carvedilol is categorized as a high-alert medication (or high-risk medication) primarily due to its complex pharmacological profile and the significant impact it has on cardiovascular hemodynamics.

As a pharmacist, I characterize Carvedilol as a “non-selective beta-blocker with alpha-1 blocking activity.” This dual mechanism makes it exceptionally effective for heart failure and hypertension, but it also necessitates strict clinical monitoring to avoid severe adverse events like profound bradycardia or hypotension.

 

Why it is Classified as High-Risk

  • Profound Hemodynamic Shifts: Because it blocks both $\beta$ and $\alpha_1$ receptors, a slight dosing error or rapid titration can lead to a sudden drop in blood pressure (orthostatic hypotension) or a dangerously slow heart rate (bradycardia).

  • Narrow Therapeutic Titration: In heart failure patients, Carvedilol must be started at very low doses (e.g., 3.125 mg) and doubled every two weeks. Starting at a “standard” dose can acutely worsen heart failure.

  • Masking Hypoglycemia: For diabetic patients, Carvedilol can mask the symptoms of low blood sugar (like tachycardia), which is a critical safety concern.

  • Bronchospasm Risk: Since it is non-selective, it can block $\beta_2$ receptors in the lungs, making it high-risk for patients with asthma or COPD.

Mechanism of Action: The Dual Blockade

Carvedilol stands apart from “selective” blockers like Bisoprolol or Atenolol:

Beta Blockade ($\beta_1$ and $\beta_2$): Reduces heart rate and the force of contraction, decreasing myocardial oxygen demand.

Alpha Blockade ($\alpha_1$): Causes peripheral vasodilation (widening of blood vessels), which reduces systemic vascular resistance and makes it easier for the heart to pump blood.

The Manufacturer’s Perspective: Quality & Compliance

From a WHO-GMP manufacturing and export standpoint, the high-risk nature of Carvedilol dictates our production protocols:

  • Low-Dose Precision: We manufacture strengths as low as 3.125 mg and 6.25 mg. Achieving content uniformity at these levels requires high-precision micronization and validated blending to ensure every tablet has the exact declared potency.

  • Stability & Sensitivity: Carvedilol is sensitive to light and moisture. We utilize Alu-Alu blister packaging to ensure its 24-month stability, especially when exporting to hot/humid Zone IVb markets like Southeast Asia and Africa.

  • Dossier & Safety Data: For international B2B trade, we provide comprehensive CTD/eCTD Dossiers including detailed “Risk Management Plans” (RMP) to assist local health authorities in understanding the safety profile for registration.

Carvedilol Tablets

 

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What are Carbimazole Tablets used for?

In the pharmaceutical industry, Carbimazole tablets (commonly manufactured in 5 mg and 20 mg strengths) are the frontline antithyroid agents used to manage an overactive thyroid gland. As a pharmacist, I characterize Carbimazole as a “prodrug” that provides a controlled, sustained reduction in the synthesis of thyroid hormones, restoring metabolic balance in patients with thyrotoxicosis.

Primary Clinical Uses

  • Hyperthyroidism: The primary treatment for an overactive thyroid, helping to alleviate symptoms like rapid heart rate, weight loss, and anxiety.

  • Graves’ Disease: Used to manage the autoimmune form of hyperthyroidism, often as part of a long-term “block and replace” or “titration” regimen.

  • Pre-operative Preparation: Administered to patients before a thyroidectomy (surgical removal of the thyroid) to ensure the patient is in a “euthyroid” (normal) state, reducing the risk of a thyroid storm during surgery.

  • Post-Radioactive Iodine Therapy: Used as an adjunct to stabilize thyroid levels while waiting for the effects of radioactive iodine treatment to manifest.

Mechanism of Action

Carbimazole is a prodrug that is rapidly converted in the body to its active metabolite, Methimazole. It works by inhibiting the enzyme thyroid peroxidase.

This enzyme is responsible for the iodination of tyrosine residues on thyroglobulin and the coupling of iodotyrosines to form $T_3$ (triiodothyronine) and $T_4$ (thyroxine). By blocking this process, Carbimazole effectively halts the production of new thyroid hormones without affecting the hormones already stored in the thyroid gland (which is why clinical improvement usually takes 1–3 weeks).

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Carbimazole is a specialized endocrine product requiring high-tier quality standards:

  • Dose Precision: Because Carbimazole is potent and requires careful titration, as a WHO-GMP manufacturer, we ensure absolute content uniformity. Patients often start at high doses (20–60 mg) and maintenance can be as low as 5 mg.

  • Stability for Export: Carbimazole can be sensitive to environmental factors. We utilize Alu-Alu or high-grade PVC/PVDC blister packaging to ensure the product remains stable during transit to Zone IVb regions (Africa, SE Asia, and the Middle East).

  • B2B & Hospital Supply: This is a core item for endocrinology departments and specialized B2B distributors. Our Mumbai-based facility provides full CTD/eCTD Dossiers to support international registration.

  • Safety Monitoring: We adhere to strict API sourcing to ensure the highest purity, which is critical given the rare but serious risk of agranulocytosis (a drop in white blood cell count) associated with this class of drugs.

Carbimazole Tablets

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What is Carbidopa Levodopa 25-250 mg used for?

In the pharmaceutical industry, Carbidopa and Levodopa (25 mg/250 mg) is the “gold standard” therapy for managing Parkinson’s Disease. As a pharmacist, I view this specific ratio as a highly sophisticated delivery system designed to ensure that the maximum amount of active medication reaches the brain while minimizing systemic side effects.

Primary Clinical Uses

  • Idiopathic Parkinson’s Disease: To alleviate the primary symptoms: resting tremors, muscular rigidity, and bradykinesia (slowness of movement).

  • Post-Encephalitic Parkinsonism: Used for movement disorders following certain viral brain infections.

  • Symptomatic Parkinsonism: Treating movement issues resulting from carbon monoxide or manganese poisoning.

    Mechanism of Action: The Synergy

This combination works by restoring dopamine levels in the brain, but it requires two components to work effectively:

Levodopa (The Precursor): Dopamine cannot cross the Blood-Brain Barrier (BBB). Levodopa is a precursor that can cross the BBB. Once inside the brain, it is converted into dopamine by the enzyme aromatic L-amino acid decarboxylase.

Carbidopa (The Protector): If Levodopa is taken alone, 95% of it is converted to dopamine in the bloodstream before it reaches the brain. This causes severe nausea and prevents the drug from working. Carbidopa is a decarboxylase inhibitor that does not cross the BBB. It “protects” the Levodopa in the bloodstream, allowing it to reach the brain intact.

Technical Formulation & Dosage (25/250)

  • The 1:10 Ratio: The 25 mg/250 mg strength is a common maintenance dose. Clinical research shows that at least 70 mg to 100 mg of Carbidopa per day is typically required to fully saturate the peripheral decarboxylase enzymes.

  • On-Off Phenomenon: As a pharmacist, I monitor patients for the “wearing-off” effect, where symptoms return before the next dose is due. This often requires precise titration.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, this CNS (Central Nervous System) drug requires rigorous quality control:

  • Content Uniformity: Because Parkinson’s patients are highly sensitive to dose fluctuations, our WHO-GMP manufacturing process uses validated double-blending to ensure that the 25 mg of Carbidopa is perfectly distributed within the 250 mg of Levodopa.

  • Stability & Sensitivity: Levodopa is sensitive to light and oxidation. We utilize Alu-Alu blister packaging or opaque HDPE bottles to ensure a 24-month shelf life, especially for export to Zone IVb regions (hot and humid) like Africa and Southeast Asia.

  • Global B2B Demand: This is a high-value, recurring maintenance medication. Our Mumbai facility provides full CTD/eCTD Dossiers to support international partners in registering the product for hospital tenders and private distribution.

Carbidopa and Levodopa Tablets

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What is Carbidopa Levodopa 10 100 mg used for?

In the pharmaceutical industry, Carbidopa (10 mg) and Levodopa (100 mg) tablets are the definitive “gold standard” for the treatment of Parkinson’s disease. As a pharmacist, I characterize this combination as a metabolic precursor strategy designed to replenish dopamine in the brain while minimizing systemic side effects.

Primary Clinical Uses

  • Idiopathic Parkinson’s Disease: Used to manage the primary motor symptoms, including tremors (shaking), rigidity (muscle stiffness), and bradykinesia (slowness of movement).

  • Post-Encephalitic Parkinsonism: Treatment of symptoms following viral brain infections.

  • Symptomatic Parkinsonism: Relief of motor deficits resulting from carbon monoxide poisoning or manganese intoxication.

Mechanism of Action: The Brain-Barrier Strategy

This combination is a classic example of pharmacokinetic synergy:

Levodopa (The Precursor): Levodopa is the immediate metabolic precursor of dopamine. Unlike dopamine itself, Levodopa can cross the Blood-Brain Barrier (BBB). Once inside the brain, it is converted into dopamine by the enzyme L-amino acid decarboxylase.

Carbidopa (The Protector): If Levodopa were taken alone, most of it would convert to dopamine in the bloodstream before reaching the brain, causing severe nausea and vomiting. Carbidopa is a peripheral decarboxylase inhibitor; it does not cross the BBB. It “protects” the Levodopa in the bloodstream, allowing more of it to reach the brain while significantly reducing peripheral side effects.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Carbidopa/Levodopa is a high-precision CNS (Central Nervous System) medication:

  • 1:10 Ratio Precision: The 10/100 mg strength maintains the critical ratio required for initial titration. As a WHO-GMP manufacturer, we utilize validated blending processes to ensure absolute content uniformity, as even minor deviations can impact the patient’s motor control (the “on-off” effect).

  • API Stability: Both APIs are sensitive to light and moisture. We utilize Alu-Alu blister packaging to prevent degradation and ensure a 24-month shelf life, which is essential for export to tropical Zone IVb regions.

  • Niche Market Demand: While common, this is a specialized product for neurology-focused B2B distributors and hospital supply chains. Our Mumbai hub provides the CTD/eCTD Dossiers and bioequivalence data required for international registration.

  • Formulation Varieties: Beyond immediate-release (IR) tablets, we also evaluate extended-release (CR) formulations to provide more stable plasma levels for advanced-stage patients.

Carbidopa and Levodopa Tablets

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What is Levodopa and Carbidopa tablet used for?

In the pharmaceutical industry, the combination of Levodopa and Carbidopa (commonly in ratios like 100/10 mg, 100/25 mg, or 250/25 mg) is the gold-standard treatment for Parkinson’s disease. As a pharmacist, I view this pairing as a classic example of “pharmacokinetic synergy”—where one drug is specifically included only to protect and enhance the delivery of the other.

Primary Clinical Uses

  • Parkinson’s Disease (Idiopathic): The primary treatment for managing motor symptoms like tremors, rigidity (muscle stiffness), and bradykinesia (slowness of movement).

  • Post-Encephalitic Parkinsonism: Used to treat parkinsonian symptoms following viral encephalitis.

  • Drug-Induced Parkinsonism: Occasionally used to manage symptoms resulting from carbon monoxide or manganese poisoning.

  • Symptomatic Improvement: It is highly effective at improving the quality of life by restoring motor control, though it does not stop the underlying neurodegeneration.

Mechanism of Action: The “Protective Delivery” Strategy

The therapeutic success of this tablet depends entirely on the interaction between these two molecules:

Levodopa (The Precursor): Parkinson’s is caused by a lack of dopamine in the brain. Since dopamine itself cannot cross the Blood-Brain Barrier (BBB), we use Levodopa, an amino acid precursor that can cross the BBB. Once inside the brain, it is converted into dopamine.

Carbidopa (The Protector): If Levodopa is taken alone, 95% of it is converted into dopamine in the bloodstream before it reaches the brain. This causes severe nausea and prevents the drug from working. Carbidopa is a peripheral dopa-decarboxylase inhibitor. It stays in the bloodstream (it cannot enter the brain) and prevents the premature conversion of Levodopa.

By adding Carbidopa, we increase the amount of Levodopa available to enter the brain by up to 80%, while simultaneously reducing the peripheral side effects like vomiting and cardiac arrhythmias.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Levodopa/Carbidopa is a high-precision CNS (Central Nervous System) product:

  • Fixed-Dose Ratio Precision: As a WHO-GMP manufacturer, we ensure the ratio (usually 4:1 or 10:1) is exact. Even minor deviations can lead to poor symptom control or increased toxicity.

  • Controlled Release (CR) Formulations: We also manufacture Sustained Release versions to provide a steady “trickle” of dopamine, which helps prevent the “on-off” phenomenon (sudden loss of drug effect) common in long-term Parkinson’s patients.

  • Oxidation Control: Levodopa is sensitive to light and air. We utilize Alu-Alu blister packaging to ensure the tablets do not darken or lose potency during export to Zone IVb regions (hot and humid) like Africa and Southeast Asia.

  • Global Export Niche: This is an essential medicine for neurology clinics and geriatric care centers worldwide. Our Mumbai facility provides full CTD/eCTD Dossier support for international B2B partners.

Carbidopa and Levodopa Tablets

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What is Carbamazepine 300 mg used for?

In the pharmaceutical industry, Carbamazepine 300 mg (often available in Modified Release or Controlled Release formulations) is a cornerstone iminostilbene derivative used as an anticonvulsant and specific analgesic. As a pharmacist, I characterize Carbamazepine as a “sodium channel stabilizer,” critical for managing neurological over-firing in both epilepsy and neuropathic pain.

Primary Clinical Uses

  • Epilepsy: Indicated as a first-line monotherapy or adjunctive treatment for partial seizures (with or without secondary generalization) and generalized tonic-clonic seizures.

  • Trigeminal Neuralgia: Considered the “gold standard” treatment for the lightning-like facial pain associated with this condition. It is often more effective than standard analgesics for this specific neuropathic pain.

    Bipolar Disorder: Used as a second-line mood stabilizer for patients with acute mania or mixed episodes who do not respond to Lithium or Valproate.

  • Diabetic Neuropathy: Occasionally used off-label to manage the chronic burning or stabbing pain associated with nerve damage in diabetic patients.

Mechanism of Action

Carbamazepine works by selectively blocking voltage-gated sodium channels in their inactive state. By binding to these channels, it slows the recovery of the channel, which prevents the high-frequency repetitive firing of action potentials in the neurons.

By stabilizing the neuronal membranes, it limits the spread of seizure activity and inhibits the transmission of pain signals in the trigeminal nerve.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Carbamazepine 300 mg is a technically demanding product that requires precise engineering:

  • Controlled Release (CR/MR) Technology: The 300 mg strength is frequently formulated as a Controlled Release tablet. As a WHO-GMP manufacturer, we utilize specialized polymer coatings to ensure the API is released slowly over 12 hours. This minimizes the “peak-to-trough” fluctuations in the blood, reducing side effects like dizziness and diplopia (double vision).

  • Bioavailability & Polymorphism: Carbamazepine is notorious for its low aqueous solubility and polymorphic forms. We utilize micronization and strict raw material testing to ensure consistent dissolution and bioequivalence against the innovator (Tegretol).

  • Stability for Global Export: Carbamazepine is sensitive to humidity, which can cause the tablets to become “hard” and fail dissolution tests. We utilize Alu-Alu or high-barrier PVC/PVDC blister packaging to ensure stability in the tropical Zone IVb climates of Africa and Southeast Asia.

  • Regulatory Documentation: Our Mumbai-based hub provides comprehensive CTD/eCTD Dossiers and stability data to support our international partners in registering this essential CNS medication.

Carbamazepine Tablets

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