Pharmaceutical Formulation Intermediates

Memantine HCL ER Pellets- Suitable for filling in Capsules- 14mg, 21mg & 28mg.

• Release pattern compared with innovator Namenda XR.
• MKPPL extended release pellets are the mixture of two types of pellets which are blended together to final strength of 10.56% w/w. this strength is dose equivalent and same pellets are used for different doses by changing the fill weight and capsule size for respective doses.
• The formulation is based on the dispersion of drug in purified water and homogenization to reduce the particle size of active ingredient and to achieve the dissolution equivalent to innovator.
• Offer complete technical package for registrations in all regulated/semi regulated markets.

Mycophenolate mofetil (MMF) is a immunosuppressant and product of mycophenolic acid, used extensively in transplant medicine, and it may play an increasing role in autoimmune disease. MMF has been introduced as a novel immunosuppressive agent in systemic lupus erythematosus (SLE), often in patients intolerant of or resistant to conventional immunosuppressive regimens.

Omeprazole Pellets 8.5%, 10%, 20%, 22%, 22.5%, 30% – Suitable for Capsules (Dose: 10 mg, 20 mg, 40 mg)

Omeprazole is a widely used proton pump inhibitor that is used in the treatment of peptic ulcers.

• Omeprazole delayed-release oral suspension is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced in the stomach.
• The product developed is comparable with innovator with respect to dissolution profile of the marketed product.
• We offer complete technical package for registrations in all regulated/semi regulated markets
• The DMF file for Omeprazole Pellets 8.5% is submitted to the USFDA and is awaiting review.
  The EDMF file for Omeprazole Pellets 8.5% is submitted with the National Authorities is Greece and Romania and is awaiting review.
• Omeprazole Pellets 8.5% BA/BE Studies have been successfully completed by the end users.
• Products protected by ongoing Patents are not offered by MKPPL.

Orlistat Pellets 50% – Ready to Fill Into Capsules (Dose: 60 mg, 120 mg)

Orlistat is a lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats. Orlistat can also help to reduce risk factors, such as high blood pressure, high cholesterol and high blood sugar which, if not treated, could lead to other diseases such as hypertension and diabetes.

• MKPPL has developed Orlistat pellets equivalent to innovator product using aqueous technology.
• Multimedia Dissolution Profile is compared with Marketed Product and similarity results were within limits in all media.
• We do offer development services in case of a requirement for different formulation/dosage/strength
• Offer complete technical package for registrations in all regulated/semi regulated markets
• MKPPL offers a patent non-infringing product.

Paclitaxel Albumin Encapsulated – Available as Lyophilized powder/100mg vials & Nano Particles (Patent Non infringing)

Paclitaxel Nano-Pellets for Injection. Paclitaxel is a mitotic inhibitor drip used in the treatment of cancer.

• MKPPL is the only the sixth company in India to have developed successfully nab-paclitaxel, the other companies being Cipla, Sun Pharma, Cadila-Zydus, Intas and Natco.
• The particle size and the encapsulation efficiency have matched the innovator’s specifications.
• In vitro cell line studies have shown that the activity is comparable to the innovator.
• Offer complete technical package for registrations in all regulated/semi regulated markets.

Pancreatin-Delayed Release Pellets-Suitable for 10000, 25000, 40000 iu unit Caps (Creon)

• Release pattern and comparative study done with innovator
• MKPPL product advantages include:
• Smaller size of pellets.
• Spherical shaped pellets compared to the innovator Creon.
• Higher drug loading possible to meet 50,000 iu lipase activity.

Offer complete technical package for registrations in all regulated/semi regulated markets.

Pantoprazole is used to treat gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the food pipe (esophagus). It is also used to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome.

Rabeprazole is an oral drug that is used for the treatment of conditions caused by acid. It is in a class of drugs called proton pump inhibitors or PPIs which block the production of acid by the stomach.

Sirolimus (initially known as Rapamycin) is a macrolide antibiotic with immunosuppressant properties. It is typically used to prevent rejection of organ transplantations especially in kidney transplants. Sirolimus has an anti-proliferative effect which makes it an effective treatment option for mesothelioma.