Carafate suspension manufacturer

Need to identify the manufacturer of Carafate suspension? The active ingredient, sucralfate, is produced by several pharmaceutical companies, but the specific manufacturer of the suspension you’re interested in will depend on the branding and packaging. Check the label carefully; the manufacturer’s name and contact information are usually printed there.

Pharmacies often stock suspensions from different suppliers depending on regional availability and contracts. Thus, you might find Carafate suspension made by different companies in various locations. Always verify the product’s authenticity by comparing the packaging details with information available on the official website of the brand you are purchasing.

If the label is unclear or you require further information, contact your pharmacist or doctor. They have access to updated databases listing pharmaceutical manufacturers and their products. They can readily provide the precise source of your Carafate suspension.

Remember: Using a reputable pharmacy is crucial for ensuring you receive a safe and authentic medication. Always consult your healthcare provider before starting or changing any medication.

Carafate Suspension Manufacturer

The primary manufacturer of Carafate suspension is Pharmacia & Upjohn, now part of Pfizer. While Pfizer currently produces and distributes numerous medications, verifying the specific manufacturer for your Carafate suspension requires checking the product label. The label clearly indicates the manufacturer and any relevant subsidiary information.

Finding Your Carafate Manufacturer

Examine the packaging carefully. You’ll find the manufacturer’s name and address printed directly on the box or bottle. This information should be readily visible. If you have difficulties locating this detail, consult your pharmacist or doctor; they can easily provide the information.

Generic Versions and Manufacturing

Several pharmaceutical companies produce generic versions of sucralfate, the active ingredient in Carafate. These generics might have different manufacturers. Again, always refer to the product packaging for precise manufacturer details for the specific generic sucralfate suspension you’re using. Your doctor or pharmacist can also confirm the manufacturer of your prescription.

Identifying the Current Manufacturer of Carafate Suspension

Currently, the manufacturer of Carafate suspension is Par Pharmaceutical, Inc. This information is readily available through official drug databases and the FDA website.

To confirm this information, you can:

1. Check the label on your Carafate suspension bottle. The manufacturer’s name and contact information should be printed clearly.
2. Visit the FDA website (fda.gov) and search for Carafate. The FDA maintains a database of approved drugs and their manufacturers.
3. Consult your pharmacist. Pharmacists are excellent resources for obtaining current and reliable information about medications.

While other companies may have manufactured Carafate in the past, Par Pharmaceutical is the current source for this medication in the US.

Information Source	Reliability	How to Access
Carafate Bottle Label	High	Examine the product packaging directly.
FDA Website (Drugs@FDA)	Very High	Search for “Carafate” on fda.gov.
Pharmacist	High	Consult your local pharmacist.

Carafate Suspension Manufacturing Process Overview

Manufacturing Carafate suspension involves several key steps. First, the active pharmaceutical ingredient (API), sucralfate, undergoes meticulous milling to achieve the desired particle size distribution for optimal suspension properties. This precise particle size is critical for both drug efficacy and the suspension’s stability.

Ingredient Preparation and Mixing

Next, accurately weighed quantities of sucralfate are blended with suspending agents like methylcellulose and xanthan gum. These agents prevent the sucralfate from settling out of the suspension. Flavoring agents, preservatives (like methylparaben and propylparaben), and purified water are then incorporated. The mixing process should carefully control shear forces to avoid damaging the API and maintain a uniform product consistency.

Quality Control and Packaging

Following mixing, the suspension undergoes rigorous quality control testing. This involves checks for particle size, viscosity, pH, sterility, and the accurate concentration of sucralfate. Once quality standards are met, the suspension is filled into appropriately sized containers, typically bottles, and sealed. Final labeling with all necessary information completes the process. Adherence to strict Good Manufacturing Practices (GMP) throughout is mandatory.

Scale-Up Considerations

Scaling up the production process requires careful attention to maintain consistent product quality. Factors such as mixing time, impeller speed, and the efficiency of the mixing equipment need to be adjusted to ensure uniform distribution of ingredients in larger batches. Validation of the manufacturing process at each scale is crucial.

Locating Carafate Suspension Manufacturing Facilities

Finding the precise location of Carafate suspension manufacturing facilities requires a multi-step approach. Directly contacting the manufacturer, Pharmacia (now part of Pfizer), is the most reliable method. Their investor relations or corporate communications department can provide details.

Alternatively, you can explore publicly available information:

• Check Pfizer’s annual reports and SEC filings: These documents sometimes list manufacturing sites.
• Search Pfizer’s website: Look for a section on manufacturing locations or facilities.
• Use online business directories: Sites like Dun & Bradstreet or Hoover’s may list Pfizer’s manufacturing sites associated with specific products.

Remember, precise facility addresses might not be publicly disclosed for security reasons. However, you should be able to identify the general region or country where the manufacturing takes place.

If you need more specific information, consider hiring a specialized research firm experienced in locating pharmaceutical manufacturing facilities. They have access to proprietary databases and can help you pinpoint the exact location.

1. Contact Pfizer directly. This is your best bet.
2. Utilize publicly available resources. Look to Pfizer’s official materials and business databases.
3. Engage a specialized research firm. This option should be considered if your search yields no results using the above methods.

Regulatory Oversight of Carafate Suspension Manufacturing

Manufacturers of Carafate suspension must adhere to strict guidelines set by the Food and Drug Administration (FDA) in the United States and equivalent agencies internationally. These regulations cover all aspects of production, from raw material sourcing to final product release.

Good Manufacturing Practices (GMP) Compliance

GMP compliance is paramount. This includes maintaining meticulous documentation of all manufacturing processes, ensuring proper equipment calibration and maintenance, and implementing rigorous quality control procedures at each stage. Regular audits by regulatory bodies verify adherence to these standards. Failure to comply can result in significant penalties, including product recalls and manufacturing shutdowns.

Active Pharmaceutical Ingredient (API) Control

Stringent controls govern the sourcing and testing of the API, sucralfate. Manufacturers must establish clear supply chains, verify the API’s purity and potency through thorough testing, and maintain detailed records of all batches used. Independent laboratory analysis often confirms the API’s quality.

Packaging and Labeling

Packaging and labeling must meet FDA requirements for accuracy, clarity, and tamper-evidence. This includes precise details on dosage, storage instructions, and potential side effects. Any changes to the packaging or labeling require prior FDA approval.

Post-Market Surveillance

Post-market surveillance is critical. Manufacturers must actively monitor product performance and promptly report any adverse events or quality issues to the regulatory authorities. This proactive approach helps ensure product safety and identify potential problems early.