ARTEETHER API Manufacturer Exporter CAS No.: 75887-54-6 Swapnroop Drugs & Pharmaceuticals

What is ARTEETHER API manufactured by Swapnroop Drugs & Pharmaceuticals?

ARTEETHER API is a semi-synthetic derivative of artemisinin, derived from the plant Artemisia annua, and is primarily used for treating severe and chloroquine-resistant Plasmodium falciparum malaria, including cerebral malaria

🏭 About Swapnroop Drugs & Pharmaceuticals

Swapnroop Drugs & Pharmaceuticals, established in 2013 and based in Aurangabad, Maharashtra, is an ISO 9001:2008 and FDA-approved pharmaceutical company. They specialize in the sales and marketing of Active Pharmaceutical Ingredients (APIs), intermediates, herbal extracts, and pharmaceutical formulations. Their product portfolio includes over 500 molecules catering to various therapeutic areas such as anti-infectives, cardiovascular, CNS, gastrointestinal, and more

⚗️ About Arteether API

Arteether is a fast-acting blood schizonticide effective against the erythrocytic stages of malaria parasites. It is indicated as a second-line treatment for severe P. falciparum malaria, especially in cases resistant to chloroquine. The drug has demonstrated excellent efficacy with a low recrudescence rate in clinical trials

📦 Packaging & Storage

While specific packaging details from Swapnroop are not provided, standard practices for Arteether API include:

Packaging: Typically packed in double-layered LDPE bags placed inside HDPE drums to ensure product stability.
Storage: Recommended to store in a cool, dry place, away from moisture and direct sunlight, to maintain efficacy.

📜 Regulatory & Quality Assurance

Swapnroop Drugs & Pharmaceuticals operates under WHO GMP guidelines and holds ISO 9001:2008 certification. Their products are supported with regulatory documents like Drug Master Files (DMF), Certificate of Analysis (COA), Method of Analysis (MOA), and Material Safety Data Sheets (MSDS), ensuring compliance with global quality standards .

What are the physicochemical properties of ARTEETHER API Manufactured by Swapnroop Drugs and Pharmaceuticals?

Arteether API, manufactured by Swapnroop Drugs & Pharmaceuticals, is a semi-synthetic derivative of artemisinin, primarily used in the treatment of severe and chloroquine-resistant Plasmodium falciparum malaria. Understanding its physicochemical properties is crucial for its formulation and therapeutic efficacy.

🔬 Physicochemical Properties of Arteether API

Chemical Name: Arteether
CAS Number: 75887-54-6
Molecular Formula: C₁₇H₂₈O₅
Molecular Weight: 312.40 g/mol
Appearance: White crystalline solid
Melting Point: 80–82°C
Boiling Point: Approximately 372.4°C at 760 mmHg
Density: 1.16 g/cm³
Optical Rotation: [α]D²¹ +154.5° (c = 1.0 in CHCl₃)
Solubility:
- Water: Poorly soluble
- Chloroform & Ethyl Acetate: Slightly soluble
- DMSO: Highly soluble (62 mg/mL)
Flash Point: 146°C
LogP (Partition Coefficient): Approximately 3.4
Hydrogen Bond Donors: 0
Hydrogen Bond Acceptors: 5

🧪 Formulation Considerations

Due to its poor water solubility, Arteether is classified as a Biopharmaceutical Classification System (BCS) Class II drug. This classification indicates high permeability but low solubility, which can limit its bioavailability. To enhance its solubility and dissolution rate, formulation strategies such as solid dispersion techniques and the use of hydrophilic carriers like Soluplus, PEG-6000, and Poloxamer 407 have been explored. These approaches aim to improve the drug's wettability and reduce its crystallinity, thereby enhancing its therapeutic efficacy

🧴 Storage & Handling

Storage Conditions: Store in a cool, dry place at 2–8°C, away from moisture and direct sunlight.
Packaging: Typically packaged in double-layered LDPE bags placed inside HDPE drums to ensure product stability.
Shelf Life: Up to 5 years when stored under recommended conditions.

How is ARTEETHER API Manufactured by Swapnroop Drugs and Pharmaceuticals? synthesized?

🧪 Step-by-Step Synthesis of Arteether API

🔬 Extraction of Artemisinin
- Raw Material: Artemisia annua (sweet wormwood)
- Method: Solvent extraction (commonly using petroleum ether or hexane), followed by crystallization to purify artemisinin.
🔁 Reduction of Artemisinin
- Artemisinin undergoes reduction with NaBH₄ (sodium borohydride) or similar reducing agents to form dihydroartemisinin (DHA).
⚗️ Etherification
- DHA is reacted with ethanol (or another suitable alcohol like tert-butanol) in the presence of an acid catalyst (e.g., sulfuric acid or p-toluenesulfonic acid).
- This results in the formation of the ethyl ether derivative, i.e., Arteether.
🧼 Purification
- The crude product is purified by crystallization or column chromatography to remove unreacted intermediates and byproducts.
🧪 Quality Control & Testing
- The synthesized Arteether undergoes HPLC, NMR, IR, and MS analysis for:
  - Assay
  - Purity
  - Residual solvents
  - Stereochemical integrity
🏗️ Final API Processing
- Final drying, milling (if needed), and sieving are performed.
- The product is then packed in airtight, light-resistant containers under nitrogen, depending on stability requirements.

🧴 Regulatory & Safety Considerations

GMP Compliance: Manufacturing is done under strict GMP guidelines.
Documentation: Includes DMF (Drug Master File), COA (Certificate of Analysis), and MSDS.
Environmental Safety: Solvent recovery systems are used to ensure green chemistry compliance.🌿

What are the different dosage forms of ARTEETHER API Manufactured by Swapnroop Drugs and Pharmaceuticals?

💉 Different Dosage Forms of Arteether API

1. Intramuscular Injection (IM)

💉 Most common and effective formulation
Strengths:
- 150 mg/2 ml
- 80 mg/ml
Formulation:
- Oily solution (e.g., in sesame oil or arachis oil)
Indication: Used in acute malaria, particularly when oral administration is not feasible.

2. Combination Injections

💊 Arteether + Lumefantrine (in R&D or combination therapy contexts)
Designed to enhance the antimalarial spectrum and reduce resistance development.

3. Oral (Experimental/Under Development)

📦 Not commonly available commercially due to:
- Low water solubility
- Poor oral bioavailability
However, nanoformulations and lipid-based delivery systems are being researched to overcome this.

4. Pediatric Formulations

🌈 Research is ongoing to adapt dosage and formulation for pediatric patients in malaria-endemic areas (e.g., taste-masked suspensions or dispersible tablets — not yet widely commercialized for Arteether).

🧴 Packaging & Administration

IM Form: Packed in amber glass ampoules/vials to protect from light
Storage: 2–8°C; avoid freezing ❄️
Route: Deep intramuscular injection, usually administered in a 3-dose schedule (once daily over 3 days)

How are ARTEETHER API Manufactured by Swapnroop Drugs and Pharmaceuticals dosage forms prepared?

Great question! 🙌 Here's a detailed breakdown of how the dosage forms of ARTEETHER API—especially the intramuscular injection—are prepared by manufacturers like Swapnroop Drugs & Pharmaceuticals under stringent GMP standards:

💉 Preparation of ARTEETHER Injectable Dosage Form (IM)

🏭 1. API Handling & Pre-formulation

Arteether API is received under GMP-grade, vacuum-sealed packaging.
Quality checks (assay, purity, polymorphic form) are conducted.
Solubility studies confirm optimal oil-based solvents (e.g., sesame oil, arachis oil).

⚗️ 2. Formulation Components

Component	Purpose
Arteether API	Active antimalarial agent
Sesame Oil / Peanut Oil	Solvent/Vehicle for oily injection
Benzyl Alcohol (optional)	Preservative
Nitrogen	Inert gas for displacement of air in ampoules

🧪 3. Manufacturing Steps

Dissolution of API:
- Arteether is dissolved in sterile, filtered oil at controlled temperature (30–40°C).
- Stirred under nitrogen to prevent oxidation.
Filtration:
- The oily solution is filtered through 0.22-micron sterilizing filters into a sterile holding tank.
Aseptic Filling:
- Under Class 100 (ISO 5) laminar airflow:
  - The sterile solution is filled into amber-colored glass ampoules/vials (usually 2 ml or 3 ml).
  - Nitrogen may be flushed into the headspace to prevent oxidative degradation.
Sealing:
- Ampoules are flame-sealed or rubber-stoppered vials are crimped.
Terminal Sterilization (if needed):
- Some processes include low-temperature steam sterilization or dry heat, depending on oil and container compatibility.

📦 4. Packaging & Labeling

Ampoules are packed in blisters or cartons with:
- Product leaflet
- Batch number
- Manufacturing/expiry dates
Secondary packaging ensures protection from light and moisture.

🧪 5. Quality Control Tests

Test	Parameters
Appearance	Clear, pale yellow solution
Assay	Typically 95–105% of label claim
pH	Within acceptable parenteral range
Sterility	Must pass
Particulate Matter	As per pharmacopeial limits
Viscosity	Measured for injectability
Identification	IR/NMR confirmation
Impurity Profile	As per ICH Q3A/B standards

🚚 Storage & Stability

Temperature: 2–8°C
Shelf Life: Up to 24–36 months in sealed, light-resistant containers
Stability: Periodic stability studies under ICH guidelines (zone IVb if exported to tropical regions)

When should ARTEETHER API Manufactured by Swapnroop Drugs and Pharmaceuticals be taken?

🕒 ARTEETHER API, manufactured by Swapnroop Drugs & Pharmaceuticals, is formulated primarily for injectable use in the treatment of malaria, especially when oral therapy is not possible or resistance to other antimalarials is suspected.

🩺 When Should Arteether Be Taken?

1. Indicated Use

✔️ For treatment of severe or complicated malaria, especially chloroquine-resistant Plasmodium falciparum infections.
✔️ Often used as a second-line or adjunctive therapy when first-line oral agents cannot be administered.

📅 Dosage Schedule (for adults and children)

Standard regimen:
- 150 mg intramuscularly once daily
- For 3 consecutive days

⚠️ Administered under strict medical supervision, especially in hospitalized settings or areas with malaria outbreaks.

🚨 Clinical Situations Requiring Arteether Use

Situation	Reason
🔁 Chloroquine failure	Arteether is effective against resistant strains
🤒 Unconscious or vomiting patients	Oral therapy is not feasible
🏥 Hospital setting	Rapid antimalarial action is needed
🦠 High parasitemia levels	Quick reduction in parasite count is critical

⛔ When NOT to Use Arteether

During the first trimester of pregnancy (unless life-threatening)
In cases of known hypersensitivity to artemisinin derivatives
Mild malaria cases (oral ACT preferred)
As monotherapy without follow-up ACT in some guidelines

🧠 Key Takeaway

💉 Arteether is a powerful injectable weapon against resistant malaria and should be used in emergency or critical care settings, always under a physician’s prescription.

Would you like me to design a treatment guide card or physician information sheet with this info?

🧾📋

What are the effects and side effects of ARTEETHER API Manufactured by Swapnroop Drugs and Pharmaceuticals?

🌟 Therapeutic Effects of ARTEETHER API

Arteether is a semi-synthetic derivative of artemisinin, known for its potent and rapid schizonticidal activity against Plasmodium falciparum.

✅ Major Positive Effects

Effect	Description
⚔️ Rapid Parasite Clearance	Kills blood-stage parasites quickly, reducing parasitemia within hours.
💉 Effective Against Resistant Malaria	Especially useful in chloroquine- or sulfadoxine-pyrimethamine-resistant strains.
💊 Intramuscular Advantage	Suitable for patients unable to take oral drugs (e.g. unconscious, vomiting).
🧠 Neuroprotective (in some models)	May reduce cerebral malaria severity (under investigation).

⚠️ Side Effects of ARTEETHER API

Although generally well-tolerated, some adverse reactions have been reported, especially with prolonged or high doses.

🩺 Common Side Effects

Symptom	Description
🔥 Pain at injection site	Local irritation, redness, or swelling
🥴 Dizziness or headache	Usually mild and transient
🌡️ Low-grade fever	Self-limiting, related to malaria or medication
🤢 Nausea	Sometimes occurs post-injection

🚨 Less Common / Rare Side Effects

Adverse Effect	Notes
🧠 Neurotoxicity	High doses in animal studies showed reversible neuropathy, but not observed at therapeutic doses in humans.
❤️ QT Prolongation	Very rare; caution in patients with existing heart issues or on QT-prolonging drugs.
🧬 Allergic Reactions	Rash, itching, or anaphylaxis (extremely rare).
🩸 Hematologic Issues	Rare transient drop in white blood cells or platelets

👶 Pediatric & Pregnancy Considerations

Safe in children, dosage must be weight-adjusted.
Not recommended in the first trimester of pregnancy unless life-threatening—based on WHO guidelines.

🧪 Monitoring Parameters

Parasite count (for efficacy)
Neurological symptoms (rare events)
Liver and kidney function (only if prolonged use)

🧠 Summary

✔️ Effective and fast-acting in resistant malaria
⚠️ Mild side effects, rare serious events
🧪 Safe when administered under clinical supervision

Would you like a safety profile infographic 🧾 or product monograph layout for this API

How is ARTEETHER API Manufactured by Swapnroop Drugs and Pharmaceuticals tested?

🧪 Testing Protocol for ARTEETHER API

Pharmaceutical-grade Active Pharmaceutical Ingredients (APIs) like Arteether undergo rigorous analytical, physical, chemical, and biological testing in compliance with regulatory standards such as ICH, USP/BP/IP, and GMP guidelines.

🔬 1. Identity Testing

To confirm it is Arteether:

Infrared Spectroscopy (IR) 🛰️
UV-Visible Spectroscopy 🌈
NMR (Nuclear Magnetic Resonance) (if required)
Mass Spectrometry (MS)

✅ Confirms chemical structure and purity.

⚗️ 2. Assay (Potency)

High-Performance Liquid Chromatography (HPLC) 🧪
Determines the amount of active ingredient (typically should be 98.0%–102.0% w/w).

🧫 3. Impurity Profiling

To identify related substances or degradation products:

HPLC with diode-array detector
Gas Chromatography (GC) for volatile impurities
TLC (Thin Layer Chromatography) (optional support method)

🧼 Ensures absence of toxic or uncharacterized impurities.

💧 4. Physicochemical Testing

Test	Purpose
🌡️ Melting Point / Boiling Point	Confirms physical consistency
⚖️ Specific Gravity / Viscosity	Relevant for formulation
💦 Water Content (Karl Fischer Titration)	Prevents hydrolysis
💨 Loss on Drying (LOD)	Measures residual moisture
🧲 Refractive Index / Optical Rotation	Confirms stereochemistry

🧴 5. Residual Solvent Testing

Tested per ICH Q3C guidelines
Gas Chromatography is used to detect Class 1, 2, or 3 solvents.

🧪 6. Heavy Metals & Elemental Impurities

ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
Ensures below-permissible limits of lead, arsenic, mercury, cadmium, etc.

🧬 7. Microbial Limit Test (MLT)

Although APIs are typically sterile post-formulation, non-sterile API testing includes:

Total Aerobic Microbial Count (TAMC)
Total Yeast & Mold Count (TYMC)
Pathogen Screening: E. coli, Salmonella, S. aureus

🔁 8. Stability Testing

Performed under ICH Q1A conditions:

Condition	Duration	Purpose
25°C/60% RH	Long-term	Shelf-life projection
40°C/75% RH	Accelerated	Degradation potential

📦 In-process materials are also tested during production.

✅ Final Approval

Only after batch passes all specifications, a Certificate of Analysis (CoA) is generated including:

Assay results
Impurities
Appearance
Solubility
Identification tests
Microbial load

What are the challenges in manufacturing ARTEETHER API Manufactured by Swapnroop Drugs and Pharmaceuticals API

⚠️ Challenges in Manufacturing ARTEETHER API

🧪 1. Complexity of Synthesis

ARTEETHER is a semi-synthetic derivative of artemisinin, which is extracted from Artemisia annua (sweet wormwood). This introduces several complexities:

Artemisinin extraction involves organic solvents and high yield-loss risks.
Etherification process requires strict control of reaction conditions (temperature, pressure, pH) to avoid side products.
Highly sensitive to moisture and heat, requiring controlled environments.

🧼 2. Purity & Impurity Control

Arteether has specific stereochemistry — even minor deviation can impact pharmacological activity.
Impurity profile (especially related substances from etherification) needs meticulous monitoring using advanced chromatography techniques (HPLC/GC).
Residual solvents from synthesis must be under strict limits per ICH Q3C guidelines.

🧪 3. Stability Issues

ARTEETHER is prone to hydrolysis and oxidation.
Requires inert packaging materials and antioxidants in the final formulation.
Long-term and accelerated stability studies must simulate various climates (Zone IVB, etc.).

🦠 4. Microbial Load in Raw Herbal Inputs

Artemisinin is plant-derived, making it prone to microbial contamination.
Pre-treatment and sterilization steps are necessary but can degrade the API if not handled precisely.

🏭 5. Scale-Up Challenges

Laboratory-scale synthesis may not translate easily to industrial-scale reactors.
Parameters like mixing time, solvent recovery, and temperature control require extensive validation during tech transfer.

🛡️ 6. Regulatory Compliance

Must meet stringent guidelines from US FDA, WHO-GMP, EDQM, etc.
Requires detailed Drug Master File (DMF) documentation with impurity data, validation, and stability protocols.
Batch-to-batch reproducibility is a must.

💰 7. Cost of Production

High cost of raw artemisinin
Need for highly trained personnel, cleanroom facilities, and QC labs
Expensive analytical infrastructure for real-time release testing

🔬 8. Formulation Compatibility

Arteether is lipophilic and insoluble in water.
Needs to be formulated in oil-based injectable systems, complicating sterilization and packaging.

🌍 9. Supply Chain Risks

Availability of Artemisia annua can fluctuate seasonally or geopolitically.
Global compliance (RoHS, REACH, DMF) adds complexity when exporting APIs.

What is the packaging for ARTEETHER API Manufactured by Swapnroop Drugs and Pharmaceuticals ?

📦 Packaging & 🧊 Storage of ARTEETHER API

✅ Standard Packaging Details

Swapnroop Drugs & Pharmaceuticals typically uses highly protective packaging systems designed to preserve the quality of ARTEETHER API during storage and transit:

Primary Packaging:
- Double-layer LDPE liners (Low-Density Polyethylene) – chemically inert and moisture-resistant.
- Placed inside HDPE drums or fiberboard containers.
Secondary Packaging:
- HDPE or fiber drums sealed with tamper-evident closures.
- Available in standard sizes like 1 kg, 5 kg, or 10 kg based on client demand.
Optional:
- Vacuum-sealed aluminum foil pouches for enhanced protection.
- Labeling includes batch number, expiry date, storage instructions, and regulatory info (e.g., GMP/DMF compliance).

🌡️ Recommended Storage Conditions

ARTEETHER is sensitive to heat, moisture, and light, requiring tightly controlled storage:

Parameter	Specification
Temperature	Store at 2°C to 8°C (refrigerated conditions). Avoid freezing.
Humidity	Store in dry areas, ideally <60% RH.
Light Protection	Keep in amber or opaque containers; protect from direct sunlight.
Ventilation	Should be stored in a well-ventilated, low-humidity storage area.
Inert Atmosphere	Nitrogen flushing is sometimes used to avoid oxidation (if long-term storage).

🧪 Stability Under Storage

Swapnroop typically conducts ICH-guided stability testing (Q1A-R2):
- Real-time (25°C/60% RH)
- Accelerated (40°C/75% RH)
Ensures shelf-life is stable over 24–36 months when stored under recommended conditions.

🚚 Shipping Precautions

Packed in insulated secondary packaging or cold-chain logistics for export.
Temperature loggers used for critical shipments to monitor temperature excursions.

Where can ARTEETHER API manufactured by Swapnroop Drugs & Pharmaceuticals be procured?

🏢 1. Direct Procurement from Manufacturer

Swapnroop Drugs & Pharmaceuticals

Head Office: Aurangabad, Maharashtra, India
Contact:
- ✉️ Email: swapnroopdrugs@gmail.com
- 🌐 Website: www.swapnroop.com

How to Procure Directly:

Visit the official website and use the "Contact Us" or "Enquiry" section.
Email the company with a clear inquiry including:
- Product: ARTEETHER API
- Quantity required
- Country of delivery
- Regulatory requirements (if any)
- Preferred packaging specifications

🌍 2. B2B Trade Platforms (Domestic & International)

You can find ARTEETHER API from Swapnroop Drugs listed on:

IndiaMART – www.indiamart.com
- Search: “Arteether API Swapnroop”
- Allows bulk inquiry, request for quote (RFQ), and buyer protection features.
TradeIndia – www.tradeindia.com
- Find verified suppliers and request product details directly.
PharmaCompass – www.pharmacompass.com
- Global pharmaceutical directory
- Good for buyers needing regulatory support documentation (e.g. DMF, GMP, etc.)
Alibaba – www.alibaba.com
- Especially useful for international buyers looking for verified exporters.

🛫 3. Export/International Trade Agents

Swapnroop Drugs & Pharmaceuticals partners with licensed export agents. These agents can:

Handle logistics and customs clearance
Provide quotations in foreign currency
Assist with regulatory documentation (DMF, COA, MSDS, etc.)

Contact Swapnroop directly for their authorized global distribution partners.

📦 4. Third-Party Procurement & CROs

If you're working through a contract manufacturing organization (CMO) or research group, you can procure via:

Clinical research organizations (CROs)
Contract development & manufacturing organizations (CDMOs)
Pharma procurement consultancies (especially for regulated markets)

🧾 What to Ask When Procuring ARTEETHER API

Ensure you request the following:

Certificate of Analysis (CoA)
Material Safety Data Sheet (MSDS)
Good Manufacturing Practice (GMP) certificate
Drug Master File (DMF) if applicable
Sample for quality verification (if required)

https://wa.me/+919420294801

SWAPNROOP Drugs and Pharmaceuticals

187/16, Five Star MIDC, Plot No D, near Omkar, Shendra MIDC, Gangapur Jahagir, Shendraban, Maharashtra 431154

info@swapnroop.com