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Mesalazine 500 mg Rectal Suppository Manufacturer in India

Mesalazine 500 mg Rectal Suppository Manufacturer in India

Mesalazine 500 mg Rectal Suppository

Mesalazine 500 mg rectal suppository is a pharmaceutical rectal dosage form containing 500 mg of mesalazine, also known as 5-aminosalicylic acid (5-ASA). It is designed for rectal administration and provides local anti-inflammatory action in the rectal mucosa. Mesalazine suppositories are used for the treatment of ulcerative proctitis and other approved inflammatory conditions affecting the rectum.

Global Entra Pharma supplies Mesalazine 500 mg rectal suppository for pharmaceutical companies, distributors, importers, wholesalers and international buyers. The product is suitable for bulk pharmaceutical supply, private-label projects, contract manufacturing and export requirements.

Mesalazine 500 mg Rectal Suppository Product Details

Product Detail Information
Product Name Mesalazine 500 mg Rectal Suppository
Active Ingredient Mesalazine
Alternative Name 5-Aminosalicylic Acid / 5-ASA
Strength 500 mg
Dosage Form Rectal Suppository
Route of Administration Rectal
Pharmaceutical Category Aminosalicylic Acid
Application Area Gastrointestinal and Rectal Health

Each 500 mg suppository contains 500 mg of mesalazine. Mesalazine acts primarily on the intestinal mucosa following rectal administration.

What Is Mesalazine 500 mg Rectal Suppository?

Mesalazine 500 mg rectal suppository is a solid pharmaceutical dosage form developed to deliver mesalazine directly to the rectal area.

Mesalazine is an anti-inflammatory active pharmaceutical ingredient belonging to the aminosalicylic acid group. When administered rectally, it provides local activity in the rectal mucosa, making the suppository dosage form particularly suitable for conditions affecting the rectum.

The product is also referred to as:

  • Mesalazine rectal suppository
  • Mesalazine 500 mg suppository
  • Mesalazine suppository 500 mg
  • 5-ASA rectal suppository
  • 5-aminosalicylic acid suppository
  • Mesalazine vaginal suppository — not applicable; this product is for rectal administration
  • Mesalazine rectal dosage form

Mesalazine 500 mg Suppository Uses

Mesalazine rectal suppositories are used for inflammatory conditions affecting the rectum.

A documented 500 mg mesalazine suppository is indicated for the management of mild to moderate ulcerative colitis limited to the rectum, also known as ulcerative proctitis.

Ulcerative proctitis is an inflammatory condition affecting the lining of the rectum. Symptoms may include:

  • Rectal bleeding
  • Frequent bowel movements
  • Rectal discomfort
  • Urgency
  • Mucus in the stool
  • Abdominal or rectal discomfort

The indication, dosage and treatment duration should follow the approved product information applicable to the specific product and market.

Mesalazine 500 mg Rectal Suppository for Ulcerative Proctitis

Ulcerative proctitis is a form of ulcerative colitis in which inflammation is limited primarily to the rectum.

Rectal mesalazine provides a dosage form that delivers the active ingredient directly to the affected area. Official product information describes rectally administered mesalazine as having largely local effects on the intestinal mucosa and submucosal tissue.

This makes mesalazine rectal suppositories an important dosage form within the gastrointestinal and inflammatory bowel disease pharmaceutical segment.

Mesalazine 500 mg Rectal Suppository Composition

The active pharmaceutical ingredient is mesalazine 500 mg per suppository.

Mesalazine is also known as 5-aminosalicylic acid (5-ASA). The finished suppository also contains suitable excipients that form the suppository base and provide the required physical properties.

The complete qualitative and quantitative composition is established according to the applicable product formulation and specification.

Mesalazine 500 mg Rectal Suppository Manufacturer in India

Global Entra Pharma supplies Mesalazine 500 mg rectal suppository for pharmaceutical companies and international buyers.

The product can be supplied for:

  • Pharmaceutical distribution
  • Bulk pharmaceutical orders
  • Import requirements
  • Private-label products
  • Contract manufacturing
  • Gastrointestinal product portfolios
  • International pharmaceutical supply
  • Export markets

Product specifications, quantities, packaging and documentation can be discussed according to the buyer's requirements.

Bulk Mesalazine 500 mg Rectal Suppository Supply

Global Entra Pharma supports bulk supply of Mesalazine 500 mg rectal suppositories for pharmaceutical businesses.

Bulk supply can be suitable for:

  • Pharmaceutical companies
  • Importers
  • Distributors
  • Wholesalers
  • Pharmaceutical traders
  • Brand owners
  • International pharmaceutical buyers

Buyers can provide the required quantity, preferred pack size, packaging requirements and destination country when requesting a quotation.

Private Label Mesalazine 500 mg Rectal Suppository

Private-label supply is available for pharmaceutical companies and distributors interested in marketing Mesalazine 500 mg rectal suppository under their own brand.

Private-label requirements may include:

  • Brand name
  • Product name
  • Pack size
  • Primary packaging
  • Secondary packaging
  • Artwork
  • Labeling
  • Package insert
  • Product documentation

Packaging and labeling can be developed according to the requirements of the intended market.

Mesalazine Rectal Suppository Contract Manufacturing

Global Entra Pharma supports contract manufacturing requirements for Mesalazine 500 mg rectal suppository.

Contract manufacturing projects can involve:

  • Active ingredient
  • Strength
  • Dosage form
  • Product specification
  • Manufacturing quantity
  • Packaging
  • Labeling
  • Artwork
  • Quality documentation
  • Export documentation

The final manufacturing and supply requirements are established according to the agreed product specification.

Mesalazine Suppository Manufacturing

Rectal suppositories are manufactured through controlled pharmaceutical processes designed to produce a uniform dosage form.

Typical manufacturing stages may include:

  1. Raw material dispensing
  2. Preparation of the suppository base
  3. Preparation of mesalazine
  4. Incorporation of the active ingredient
  5. Mixing and homogenization
  6. Filling or moulding
  7. Cooling and setting
  8. Demoulding
  9. Visual inspection
  10. In-process testing
  11. Finished-product testing
  12. Primary packaging
  13. Secondary packaging
  14. Finished-product release

The actual manufacturing process depends on the approved formulation, manufacturing procedure and product specification.

Mesalazine 500 mg Suppository Quality Control

Quality control is an important part of pharmaceutical suppository manufacturing.

Depending on the applicable product specification, testing may include:

  • Appearance
  • Average weight
  • Weight variation
  • Identification
  • Assay
  • Content uniformity
  • Disintegration
  • Drug-release testing where applicable
  • Microbiological testing
  • Stability testing

The exact analytical methods and acceptance criteria are established according to the applicable product specification.

Mesalazine 500 mg Rectal Suppository Packaging

Mesalazine rectal suppositories can be supplied in suitable pharmaceutical packaging according to the product and destination-market requirements.

Packaging options may include:

  • Individual-unit packaging
  • Strip packaging
  • Blister packaging
  • Printed cartons
  • Package inserts
  • Private-label packaging
  • Export packaging

Pack size, artwork, labeling and packaging configuration can be discussed according to the buyer's requirements.

Mesalazine Suppository Documentation

Pharmaceutical buyers may require technical and quality documentation for product evaluation, registration or import purposes.

Depending on the order and destination market, applicable documentation may include:

  • Certificate of Analysis
  • Product specification
  • Stability information
  • Manufacturing information
  • Packaging information
  • Quality documentation
  • Product-related technical documents
  • Export documentation

Documentation requirements can vary according to the destination country and applicable pharmaceutical requirements.

Mesalazine 500 mg Rectal Suppository Export from India

Global Entra Pharma supports Mesalazine 500 mg rectal suppository export from India for international pharmaceutical buyers.

Export requirements can include discussions regarding:

  • Product quantity
  • Strength
  • Pack size
  • Packaging
  • Labeling
  • Private-label requirements
  • Product documentation
  • Destination country

International buyers can provide their product and supply requirements for further discussion.

Mesalazine Rectal Suppository Supplier

Global Entra Pharma supplies pharmaceutical products to companies looking for pharmaceutical sourcing and international supply solutions.

For Mesalazine 500 mg rectal suppository, buyers can discuss:

  • Bulk quantity
  • Product specifications
  • Packaging
  • Private labeling
  • Contract manufacturing
  • Documentation
  • Export requirements

The product can be included in gastrointestinal and inflammatory bowel disease pharmaceutical portfolios.

Mesalazine 500 mg Suppository for Gastrointestinal Health

Mesalazine is widely associated with pharmaceutical treatment of inflammatory bowel conditions. Rectal formulations are particularly relevant when inflammation is localized to the rectum.

Mesalazine suppositories therefore form part of pharmaceutical portfolios covering:

  • Gastrointestinal health
  • Inflammatory bowel disease
  • Ulcerative colitis
  • Ulcerative proctitis
  • Rectal inflammatory conditions

Mesalazine 500 mg Suppository Storage

Storage requirements depend on the specific formulation, packaging and approved product information.

A documented 500 mg mesalazine suppository product specifies storage not above 30°C and recommends keeping the product in its original container to protect it from light.

For a particular commercial product, the storage conditions stated on the applicable packaging and product documentation should always be followed.

Mesalazine 500 mg Suppository Shelf Life

The shelf life of a pharmaceutical suppository is established through stability studies.

A documented 500 mg mesalazine suppository has a stated shelf life of 36 months under its specified storage conditions.

The expiry date and storage conditions for a specific batch should always be checked on the product packaging and batch documentation.

Request a Quote for Mesalazine 500 mg Rectal Suppository

If you are looking for a Mesalazine 500 mg rectal suppository manufacturer or supplier in India, contact Global Entra Pharma.

Please provide:

  • Required quantity
  • Preferred pack size
  • Packaging requirements
  • Private-label requirement
  • Destination country
  • Required documentation

Global Entra Pharma can discuss the product and supply requirements for your pharmaceutical business.

Frequently Asked Questions

What is Mesalazine 500 mg rectal suppository?

Mesalazine 500 mg rectal suppository is a solid pharmaceutical dosage form containing 500 mg of mesalazine and intended for rectal administration.

What is Mesalazine suppository used for?

Mesalazine rectal suppositories are used for inflammatory conditions affecting the rectum. A documented 500 mg product is indicated for mild to moderate ulcerative colitis limited to the rectum, known as ulcerative proctitis.

What is the strength of the product?

Each suppository contains 500 mg of mesalazine.

What is another name for mesalazine?

Mesalazine is also known as 5-aminosalicylic acid (5-ASA).

Is Mesalazine 500 mg a rectal suppository?

Yes. Mesalazine 500 mg is available as a rectal suppository dosage form.

Is Mesalazine suppository used for ulcerative proctitis?

Yes. Rectal mesalazine suppositories are used for ulcerative proctitis according to applicable product indications.

Is Mesalazine 500 mg suppository for rectal use?

Yes. The dosage form is designed specifically for rectal administration.

Do you supply Mesalazine 500 mg suppositories in bulk?

Yes. Global Entra Pharma supports bulk pharmaceutical supply requirements.

Can Mesalazine 500 mg rectal suppository be supplied as a private-label product?

Yes. Private-label requirements involving branding, packaging, artwork and labeling can be discussed.

Do you provide contract manufacturing?

Yes. Contract manufacturing requirements can be discussed according to product specifications, quantity, packaging and destination market.

Can Mesalazine 500 mg suppositories be exported from India?

Yes. Global Entra Pharma supports international pharmaceutical supply and export requirements from India.

Can the packaging be customized?

Yes. Pack size, artwork, labeling and packaging configuration can be discussed according to the order requirements.

What documentation is available?

Depending on the product and destination market, applicable quality, technical and export documentation can be discussed with the buyer.

How can I request a quotation?

Send your required quantity, pack size, packaging requirements and destination country to Global Entra Pharma for a quotation.


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