Ferric Carboxymaltose 9007-72-1 Manufacturer Supplier Exporter MEDIOCON INC

 

Ferric Carboxymaltose Manufactured by MEDIOCON INC

 

   Name: Ferric Carboxymaltose

CAS No:   9007-72-1

Molecular Weight:  788.4 g/mol

Molecular formula:  C₂₄H₄₄FeO

Synonyms: Iron dextri-maltose.

Appearance:  dark brown, non-transparent, colloidal solution.

 Solubility :  It is freely soluble in water but insoluble in most organic solvents

Use :

Ferric carboxymaltose is used to treat:

- Iron deficiency anemia: particularly in patients with chronic kidney disease or those who cannot tolerate oral iron

- Iron deficiency: when oral iron is ineffective or poorly tolerated

 

It's administered intravenously. Consult a healthcare professional for guidance.

 How is  Ferric Carboxymaltose manufactured by MEDIOCON INC Synthesized?

Ferric carboxymaltose is synthesized through:

- Reaction of ferric hydroxide with carboxymaltose: forming a stable iron-carbohydrate complex

- Purification: removing impurities and excess reactants

- Sterilization: ensuring the final product is sterile

This process yields a stable, injectable iron complex.

What are the different  dosage forms  of   Ferric Carboxymaltose Manufactured  by  MEDIOCON INC?

Ferric carboxymaltose is available as:

- Intravenous injection: solution for injection (50mg/mL)

- Single-use vials: containing 500mg or 1000mg of iron

 

Administration is typically done in a healthcare setting. Consult local guidelines.

 How Ferric Carboxymaltose Manufactured by MEDIOCON INC   Dosage Forms are prepared?

Ferric carboxymaltose dosage forms are prepared through:

- Manufacturing process: synthesis and purification of ferric carboxymaltose

- Sterile filling: filling vials under aseptic conditions

- Quality control: testing for sterility, stability, and iron content

- Packaging: labeling and packaging vials for distribution

This ensures a sterile, stable, and effective product.

What are the appropriate Dosage forms of Ferric Carboxymaltose Manufactured  by  MEDIOCON   INC?                

The appropriate dosage form of Ferric Carboxymaltose is:

- Intravenous (IV) injection: typically administered in a healthcare setting

 

Dosage and administration may vary based on patient factors, such as iron deficiency severity and renal function. Consult a healthcare professional for guidance.

When should Ferric Carboxymaltose Manufactured by MEDIOCON INC be taken?

Ferric carboxymaltose is administered intravenously, typically:

- As prescribed by a doctor: dosage and frequency depend on individual patient needs

- In a healthcare setting: under medical supervision

No self-administration is recommended.

 What are the effects And Side effects of Ferric Carboxymaltose Manufactured by MEDIOCON INC?

Ferric carboxymaltose is administered intravenously, typically:

- As prescribed by a doctor: dosage and frequency depend on individual patient needs

- In a healthcare setting: under medical supervision

 

No self-administration is recommended.

  How is Ferric Carboxymaltose Manufactured by MEDIOCON  INC  Tested Qualitatively?

Ferric carboxymaltose is tested qualitatively through:

- Spectroscopy (e.g., IR): confirms molecular structure

- HPLC (High-Performance Liquid Chromatography): detects purity and impurities

- Chemical tests: identifies iron content and complexation

- Physicochemical tests: evaluates appearance, solubility, and stability

These tests ensure the identity, purity, and quality of ferric Carboxymaltose.

   Which tests are performed on Ferric Carboxymaltose Manufactured by  MEDIOCON INC ?

Tests performed on Ferric Carboxymaltose include:

- Assay: determines iron content

- Purity tests: detects impurities

- Sterility testing: ensures absence of microorganisms

- Endotoxin testing: detects bacterial endotoxins

- Physicochemical tests: evaluates appearance, solubility, and stability

These tests ensure the quality, safety, and efficacy of Ferric Carboxymaltose.

What are the challenges in Manufacturing of Ferric Carboxymaltose Manufactured by MEDIOCON   INC API?

The challenges in manufacturing Ferric Carboxymaltose API include:

- Complex synthesis process: ensuring consistent quality and yield

- Raw material quality control: sourcing high-quality starting materials

- Stability and degradation: maintaining stability during production and storage

- Sterility and endotoxin control: ensuring the product is sterile and endotoxin-free

- Regulatory compliance: meeting stringent pharmaceutical regulatory requirements

- Batch-to-batch consistency: achieving consistent quality across production batches

These challenges require careful process control, validation, and quality assurance

What are the challenges in manufacturing of Ferric Carboxymaltose Manufactured by MEDIOCON  INC ’s Dosage forms?

The challenges in manufacturing Ferric Carboxymaltose dosage forms include:

- Sterility maintenance: ensuring the product remains sterile during filling and packaging

- Stability and degradation: maintaining stability of the iron complex during manufacturing and storage

- Particle size control: ensuring uniform particle size for consistent efficacy

- Compatibility with packaging: ensuring the dosage form is compatible with the packaging material

- Regulatory compliance: meeting stringent regulatory requirements for parenteral products

- Batch-to-batch consistency: achieving consistent quality across production batches

These challenges require careful process control, validation, and quality assurance.

What is the Packing for Ferric Carboxymaltose Manufactured by MEDIOCON INC?

Ferric Carboxymaltose is typically packaged in:

- Single-use vials: containing a specific dose (e.g., 500mg or 1000mg of iron)

- Sterile, sealed containers: to maintain sterility and prevent contamination

- Protective packaging: to prevent damage during transportation and storage

The packaging may vary depending on the manufacturer and local regulations.

What is shelf life Of Ferric Carboxymaltose Manufactured by MEDIOCON INC? 

Ferric Carboxymaltose has varying shelf lives based on different sources:

- 3 years: When stored at 20°C, as powder

- 2.5 years: For 100 mg Ferric Carboxymaltose Injection, stored in a dry place

- After dilution: Ferric Carboxymaltose solution can be stored for up to 72 hours when diluted with sterile 0.9% sodium chloride solution

 

It's essential to note that storage conditions and expiration dates may vary depending on the manufacturer and specific product. Always check the product label or consult with the manufacturer for the most accurate information.

What should the label claim for Ferric Carboxymaltose Manufactured by MEDIOCON INC   Include?

The label claim for Ferric Carboxymaltose should include:

- Product name: Ferric Carboxymaltose Injection

- Concentration: amount of iron per mL (e.g., 50mg/mL)

- Volume: total volume of the solution (e.g., 10mL)

- Dose: recommended dose and administration instructions

- Storage conditions: temperature, light protection, and other storage requirements

- Expiration date: date after which the product should not be used

- Manufacturer: name and address of the manufacturer

- Batch number: unique identifier for the batch

- Warning statements: any relevant warnings or precautions

This information ensures safe and effective use of the product.

Where can Ferric Carboxymaltose Manufactured by MEDIOCON INC are procured?

Ferric Carboxymaltose Manufactured by MEDIOCON INC   can be procured from various sources, depending on your location and requirements. Here are some options:

FOR API

MEDIOCON INC

Add: B-2, ARCH SARTHAK BUILDING, N-7 CIDCO

CHATRAPATI SAMBHAJI NAGAR-431003, MAHARASHTRA, INDIA

Mob/WhatsApp No: +91-8007719681, +91-9309999757, +91-9834786939

Sales Department: Email: sales@mediocon.com

Purchase Department: Email: purchase@mediocon.com

Marketing Department: Email: mktg@mediocon.com

HR Department: Email: hr@mediocon.com

Accounts Department: Email: accounts@mediocon.com          

Factory Address: Plot No 11, Shendra MIDC, Aurangabad-431154, Maharashtra, India Website:  www.mediocon.com 

Email id:info@mediocon.com           

GST No: 27DHUPM2366D1ZZ

For Dosage Forms :

- Online Marketplaces: You can find Ferric Carboxymaltose Manufactured by MEDIOCON INC   products on online marketplaces like Amazon or e- commerce websites specializing in pharmaceuticals or skincare products.

Local Pharmacies or Skincare Stores: You can also check with local pharmacies or skincare stores in your area for Ferric Carboxymaltose Manufactured by MEDIOCON INC products.

Remember to ensure the quality and authenticity of the Ferric Carboxymaltose Manufactured by MEDIOCON INC product, regardless of the procurement source.