Ambrisentan API in Pakistan: Raw Material for Pharmaceutical Formulators

Ambrisentan API in Pakistan: Raw Material for Pharmaceutical Formulators

Product Name: Ambrisentan (Active Pharmaceutical Ingredient)

Brand/Supplier: Morgan

Therapeutic Category: Endothelin Receptor Antagonists (ERA)

Indications: Pulmonary Arterial Hypertension (PAH)

Notice: This catalog page is intended exclusively for B2B pharmaceutical manufacturers, contract manufacturing organizations (CMOs), and R&D facilities. Ambrisentan supplied by Morgan is a raw Active Pharmaceutical Ingredient (API) for formulation and research. It is not a finished medicine for patient use.

About Morgan: Morgan Chemicals (Pvt.) Ltd. is a pharmaceutical raw material trading and distribution company. We source APIs from DRAP-registered and internationally certified manufacturers and supply exclusively to licensed pharmaceutical companies, CMOs, and research facilities. We do not manufacture APIs or sell finished medicines.

Product Overview

For pharmaceutical facilities developing treatments for severe vascular conditions, securing a stable supply of high-selectivity active ingredients is critical. Ambrisentan is a propanoic acid-based Active Pharmaceutical Ingredient (API) classified as an Endothelin Receptor Antagonist (ERA).

Pharmacologically, it operates with a high affinity and selectivity for the endothelin type-A (ETA) receptor. By blocking the binding of endothelin-1—a peptide that induces severe vasoconstriction—Ambrisentan effectively counteracts pulmonary arterial narrowing.

In finished pharmaceutical dosages (typically 5 mg and 10 mg oral film-coated tablets), this API is indicated for treating Pulmonary Arterial Hypertension (PAH, WHO Group 1). From a formulation standpoint, Ambrisentan’s ETA selectivity provides a distinct advantage over older, non-selective ERAs, as it preserves the beneficial clearance and vasodilatory functions of the ETB receptor.

Sourcing Ambrisentan in Pakistan for Local Manufacturing

Importing specialty cardiovascular APIs into South Asia often involves navigating complex customs procedures, extended freight timelines, and strict regulatory hurdles. Relying on overseas suppliers can disrupt commercial batch schedules and delay market entry.

By procuring Ambrisentan Pakistan through Morgan, local pharmaceutical plants can bypass these logistical bottlenecks. We provide commercial and pilot-scale quantities that meet international pharmacopeial standards while directly aligning with domestic requirements.

Partnering with Morgan provides your facility with several operational benefits:

• DRAP Registration Support: Morgan supplies all necessary compliance documentation, including open parts of the Drug Master File (DMF), stability profiles, and impurity data. This streamlines your Drug Regulatory Authority of Pakistan (DRAP) submissions.
• Localized Supply Chain: We manage inventory locally to eliminate international transit delays. Morgan sources and supplies your production timelines remain on track, protecting you from unexpected raw material shortages.
• Batch Consistency: Consistent manufacturing requires consistent raw materials. Every shipment coordinated by Morgan includes a detailed Certificate of Analysis (CoA) issued by the original manufacturer. We ensure uniform chemical purity by sourcing exclusively from verified, GMP-certified manufacturers, moisture limits, and particle size distribution to ensure predictable behavior during milling, blending, and tableting.

Technical Specifications for QA & R&D

For R&D formulators and Quality Control (QC) teams, the chemical integrity of the active ingredient dictates the success of the finished drug. Morgan’s Ambrisentan API is manufactured in GMP-compliant facilities under strict quality controls.

• Chemical Name: (2S)-2-(4,6-Dimethylpyrimidin-2-yl)oxy-3-methoxy-3,3-diphenylpropanoic acid
• CAS Number: 177036-94-1
• Appearance: White to off-white crystalline solid
• Molecular Formula: C22H22N2O4
• Molecular Weight: 378.42 g/mol
• Assay / Purity (HPLC): ≥ 99.0%
• Solubility: Specific solubility data for standard organic solvents and aqueous buffers is detailed in Morgan's technical data sheet, assisting your team with wet granulation and dissolution profiling.

Manufacturing and Handling Guidelines

Ambrisentan is a highly potent therapeutic compound with documented teratogenic risks. Any facility processing this API must implement rigorous occupational exposure controls.

• Storage Conditions: Store the raw API in well-closed, light-resistant containers. Maintain climate-controlled conditions (as specified by the specific batch protocol, often 2-8°C) to prevent chemical degradation.
• Occupational Safety: Due to strict warnings regarding embryofetal toxicity, manufacturing personnel must follow advanced safety protocols. Operators require high-level Personal Protective Equipment (PPE), including specialized respirators, double-layered nitrile gloves, and full-body protective suits. Weighing, milling, and compounding should ideally occur within closed-loop isolators or high-containment glove boxes to prevent inhalation or dermal absorption.

Distributor Disclaimer: Morgan Chemicals is a pharmaceutical raw material trading and distribution company. This API is sourced from DRAP-registered, GMP-certified manufacturing partners. Morgan Chemicals does not manufacture APIs, does not hold DRAP manufacturing registration, and does not sell finished medicines. This product is supplied exclusively to licensed pharmaceutical companies, CMOs, and research facilities in Pakistan — not for individual or consumer sale.