Buprenorphine HCl API – High Purity, Pharmaceutical Grade

Product Overview: Buprenorphine HCl API is a high-purity opioid receptor partial agonist used as an analgesic and in the treatment of opioid dependence. Manufactured to meet rigorous Good Manufacturing Practice (GMP) standards, this pharmaceutical-grade compound ensures safety, efficacy, and reliability for formulation into pain relief and addiction treatment medications.

Key Features & Benefits

✅ Pharmacological Action – Partial opioid agonist for effective pain management and opioid dependency support.
✅ High Purity – White or almost white crystalline powder with exceptional quality.
✅ GMP Compliant – Produced under strict regulatory oversight.
✅ COA Available – Certificate of Analysis provided upon request.
✅ Bulk Availability – Ready for global supply with efficient shipping.
✅ Storage: Below 30°C | Shipping: Maintain below 30°C.

Regulatory & Compliance

• Pharmacopoeia Standards: Compliant with USP/EP/BP/JP.
• Documentation: COA is available; DMF support is available upon request.

Technical Specifications

Storage & Handling

• Storage: To preserve stability, keep below 30°C in a dry, controlled environment.
• Shipping: Shipped under conditions mirroring storage requirements (below 30°C) to ensure product integrity.

Uses of Buprenorphine

• Buprenorphine HCl is widely used in:
  • Pain Management: Provides effective analgesia with a lower risk of respiratory depression compared to full opioid agonists.
  • Opioid Dependence Treatment: A key component in medication-assisted therapy, often paired with naloxone to prevent misuse.

  Furthermore, Pluvia Endo produces the base API, Buprenorphine Base. It is also available in various forms, including sublingual tablets, buccal films, and transdermal patches.

Mechanism of action

• Buprenorphine Hydrochloride binds to the mu-opioid receptors in the brain, producing partial agonist effects. This means it can produce some of the same effects as other opioids, such as pain relief and euphoria, but to a lesser extent.
• It also has antagonist effects at the kappa-opioid receptors. This means it can block the effects of other opioids, making it difficult to get high from them.

Side effects

• The most common side effects of this Medicine API include constipation, nausea, vomiting, drowsiness, and headache.
• More serious side effects can occur, such as respiratory depression, allergic reactions, and adrenal insufficiency.

Precautions

• People who are allergic to Vonage Pharma’s (Former Pluvia Endo) Buprenorphine Hydrochloride or who have severe respiratory depression should not use it.
• Healthcare providers should also use it with caution in people with liver or kidney problems, pregnant or breastfeeding women, and people who are taking other medications that can cause respiratory depression.

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