In the pharmaceutical industry, Bromocriptine Mesylate is a dopamine receptor agonist derived from ergot alkaloids. As a pharmacist and manufacturer, I must provide a clear distinction: Bromocriptine is NOT an abortifacient (it does not stop or terminate an existing pregnancy), but it has significant effects on fertility and the maintenance of early pregnancy.
At your WHO-GMP facility in Mumbai, you likely handle this molecule for treating hyperprolactinemia, acromegaly, and Parkinson’s disease.
Safety and Impact on Pregnancy
Mechanism: The Prolactin-Dopamine Axis
Bromocriptine mimics the action of dopamine in the pituitary gland, which has a direct impact on the reproductive cycle.
Dopamine Agonism: Bromocriptine binds to receptors on the lactotroph cells of the anterior pituitary.
Prolactin Inhibition: This binding inhibits the synthesis and secretion of Prolactin.
Restoring GnRH: High prolactin levels normally suppress Gonadotropin-Releasing Hormone (GnRH). By lowering prolactin, Bromocriptine allows GnRH to pulse normally again, triggering the release of FSH and LH, which leads to ovulation.
Corpus Luteum Support: In some species, high doses could theoretically interfere with the corpus luteum (which maintains early pregnancy), but in humans, this effect is not considered a reliable or safe method to interfere with pregnancy.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai, Bromocriptine is a high-potency, specialty molecule:
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Marketing Accuracy: When listing Bromocriptine 2.5 mg tablets on your digital platforms, it is vital to categorize it under “Endocrinology” or “Infertility” rather than general gynecology. This demonstrates your firm’s technical depth to B2B buyers.
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Stability & Light Sensitivity: Bromocriptine is highly sensitive to light and oxidation. At our facility, we utilize Alu-Alu blister packaging and strictly controlled manufacturing environments to ensure a 36-month shelf life. This is a critical USP for export to Zone IVb tropical regions.
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The “Safety Profile” USP: Since many patients take Bromocriptine right up until they realize they are pregnant, providing a technical summary of its non-teratogenic (safe for the fetus) nature in your Product Information Leaflet (PIL) is a major value-add for international distributors.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm in registering this specialty product in regulated markets like the Middle East and Southeast Asia.