Mycophenolate Mofetil Capsules GMP

Product Details
Customization: Available
Application: Internal Medicine
Usage Mode: For oral administration
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Management System Certification
ISO 9001, ISO 9000, GMP, LEED
Export Year
2015-04-30
  • Mycophenolate Mofetil Capsules GMP
  • Mycophenolate Mofetil Capsules GMP
  • Mycophenolate Mofetil Capsules GMP
  • Mycophenolate Mofetil Capsules GMP
  • Mycophenolate Mofetil Capsules GMP
  • Mycophenolate Mofetil Capsules GMP
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Basic Info.

Model NO.
medicine
State
Solid
Shape
Capsules
Type
Organic Chemicals
Pharmaceutical Technology
Chemical Synthesis
OEM
Available
Shelf Life
3 Years
Specification
250mg
Origin
China
HS Code
3004909099
Production Capacity
2, 000, 000units/Day

Product Description

Mycophenolate Mofetil Capsule 
Indication
Mycophenolate mofetil is suitable for preventing organ rejection in patients receiving allogeneic kidney or liver transplantation. Mycophenolate mofetil should be applied simultaneously with cyclosporine A or tacrolimus and corticosteroids.
Usage and Dosage
Kidney Transplantation Adult: For kidney transplant patients, oral dose of 1g bid (2g daily dose) is recommended. Although 1.5 g per dose (daily dose 3 g) was used in clinical trials and it was safe and effective, there was no effective advantage in kidney transplantation. Patients who received 2 g of mycophenolate mofetil per day had better overall safety than those who received 3 g. 
Liver Transplantation: The recommended oral dose for adult liver transplant patients is 0.5-1g bid (1-2g daily dose). Transplantation of mycophenolate mofetil should begin as soon as possible after kidney, heart or liver transplantation. Food had no effect on MPAAUC but decreased MPACmax by 40%. Therefore, it is recommended that mycophenolate be taken on an empty stomach. However, for stable renal transplant patients, mycophenolate mofetil can be taken with food if needed. 
Patients with abnormal liver kinetics: Renal transplantation patients with severe hepatic parenchymal disease do not need dose adjustment. However, it is unclear if other liver diseases need to be dose-adjusted. There are no data on heart transplant patients with severe hepatic parenchymal lesions. Elderly: The recommended recommended dose for kidney transplantation is 1 g bid, and for liver transplant patients 0.5-1 g bid. Dose Adjustment For kidney transplant patients with severe chronic renal impairment (glomerular filtration rate less than 25 ml/min/1.73 m2), after the early postoperative period, doses greater than 1 g per bid should be avoided. And these patients need close observation. Patients with delayed graft function after renal transplantation do not need to adjust doses (see Pharmacology and Toxicology, Pharmacokinetics, and Precautions). Patients with severe chronic renal insufficiency who have undergone heart or liver transplantation are not available. If the potential benefit is greater than the potential harm, mycophenolate mofetil can be used after a heart or liver transplant in patients with severe chronic renal insufficiency. If there is neutropenia (absolute neutrophil count 1.3×10 3 /μL), mycophenolate mofetil should be suspended or reduced, and appropriate diagnostic tests and appropriate treatment.
Contraindications
Allergic reactions to this drug have been observed, so mycophenolate mofetil is contraindicated in patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid, or other components of the drug. Mycophenolate mofetil intravenous formulations are contraindicated in patients with hypersensitivity to polysorbate 80 (Tween).


Our factory
This product is produced in our GMP factory, all our facility has past China GMP, and also officially certificated by more than ten countries' MOH. 
Our Service
We can specially develop the products per customers' specification.
We can offer OEM service with customers' private brands and labels.
We can offer excellent after-sale service and professional technical support.


Our Quality control system
In manufacturing, quality is what sustains our life.  Starting from the material selection, there are many factors that contribute to the quality control process.  Our manufacturing facility is GMP certified. Quality Control (QC) and monitoring procedures are built into every aspect of our work.
Our Quality Control System is outlined below:

  1. Initial inspection (such as raw material, excipients, package materials, etc.)
  2. In-process inspection (make sure that each testing items should be qualified )
  3. Final inspection before shipment of each order. 
  4. Provide temperature control recorder when it is necessary for special market before loading.

Our Registration Team and technical support
We have experienced team to provide qualified and professional registration documents for most of countries. Up to present, we have registered more than hundred products and exported to more than 20 countries. Especially including those in Asia, Africa, South America, Middle east area and East Europe.
We can provide regulatory documents
    1. GMP Certificate / CE Certificate
    2. Free sales certificate 
    3. Certificate of Pharmaceutical Products
    4. Manufacture License
    5. CTD Dossier. 
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