MURLI KRISHNA PHARMA

OLISTAT PELLETS 50%

COMPANY PROFILE Murli Krishna Pharma is an EU-GMP/ WHO-GMP and PIC/S

approved plant. We manufacture pre finished formulation intermediates that can

be directly employed into formulating solid dosage forms, can be blended with suspension base for use in suspensions. We also have developed nano particles for direct use in ophthalmic solutions and injectables

We are one among the global top 10 NDDS manufacturers and one of the five regulatory compliant and regulatory approved manufacturers of pre finished formulation intermediates.

We provide a complete patient friendly solution to the generic manufacturers of the World.

MURLI KRISHNA PHARMA

Factory-MKPPLThe facility of Murli Krishna Pharma Pvt. Ltd. for manufacturing of coated pellets, is situated at Plot. No. D-98 MIDC, Ranjangaon. The facility is certified by Food and Drug administration Maharashtra State.

 Factory Registration and License No.: PD - 162 and PD - 115

Images of Extruders & Spheronizers in our R &D

Orlistat 50.0% Pellets -Fill Weight

Mesh Size Dose Fill Wt. Capsule Size Capsules per kg of pellets

14 # 20 / 18 # 30 120 mg 240 mg 1 4166

14 # 20 / 18 # 30 60 mg 120 mg 3 8333

18 # 30 120 mg 240 mg 2 4166

18 # 30 60 mg 120 mg 4 8333

Number of Capsules per kg of MKPPL Pellets

Pellets offer a more uniform surface and also have a particle size distribution in a narrow window compared to granules. This ensures a better dose uniformity and also a more uniform transfer of dose.

Description:Anti-Obesity drugReversible inhibitor of lipases. Used for losing weight

Patent HoldersRoche- Switzerland

Our Non-InfringementPatent non-infringing process

Comparative Dissolution Data

Time(Min)

Dissolution (%)Of MKPPL

B.No. PDL/ORE-010609

Dissolution (%) of XENICAL B.No. M1425U

0 0 0

1071.5 76.0

2083.4 88.1

3090.1 93.5

4592.6 96.9

6096.9 99.3

ORLISTAT PELLETS

5. Dissolution Profile:

Differential Factor (F1) was found to be 4.25 (0-15 is acceptable)Similarity Factor (F2) was found to be 69.48 (50-100 is acceptable)

Conclusion: From the above values of F1 and F2, it can be concluded that Orlistat pellets manufactured at Murli Krishna Pharma compare favorably with that of the Innovator product.

Dissolution Profile

SPECIFICATIONS-MKPPL

Variations of the Product:

Percentage: 50%Mesh Size: 14 # 20, 18 # 30

Documentation Availble:DMF in CTD format is availableStability Data- Accelerated and Long term stability is available.

Registrations :Our product was registered in Iran, Mexico, Columbia, Switzerland, Europe, Egypt, Romania

Bangladesh, Pakistan, Turkey, etc…

ORLISTAT PELLETS

Orlistat 50.0% Pellets -Fill Weight

Mesh Size Dose Fill Wt. Capsule Size Capsules per kg of pellets

14 # 20 / 18 # 30 120 mg 240 mg 1 4166

14 # 20 / 18 # 30 60 mg 120 mg 3 8333

18 # 30 120 mg 240 mg 2 4166

18 # 30 60 mg 120 mg 4 8333

Number of Capsules per kg of MKPPL Pellets

Pellets offer a more uniform surface and also have a particle size distribution in a narrow window compared to granules. This ensures a better dose uniformity and also a more uniform transfer of dose.

THE PRODUCT PORTFOLIO

Product -Commercialized

Recently Developed Under-Development

Orlistat  Pellets Aprepitant Pellets Mycophenolate Mofetil Pellets

Clarithromycin Pellets/Granules

Azithromycin Taste Masked Granules

Paclitaxel Nano Particles

Itraconazole Pellets Sirolimus Micro Pellets Brinzolamide Micro Pellets

Lansoprazole Pellets/Micro Pellets

Tacrolimus Pellets/Micro pellets

Duloxetine HCL EC Pellets

Esomeprazole Pellets Tamsulosin HCL SR Pellets

Voriconazole Micro Pellets

Pantoprazole Pellets Mesalamine Pellets Venlafaxine SR pellets

Omeprazole Pellets Everolimus Micro Pellets

DOCUMENTS AVAILABLE

DOCUMENTATIONS:

DMF: EDMF in CTD format is available.

STABILITY DATA: Both accelerated & Long Term stability is available.

WORLDWIDE - SUPPLIES

MKPPL product was Exported to: Mexico Columbia Turkey Iran Egypt Cyprus Bangladesh

For further information please feel free to contact our Marketing team.

Kind Attn: Ms. Sudha Murli Krishna Pharma P. Ltd INDIA

D-98, M.I.D.C. Ranjangaon, Tal. ShirurDist. Pune 412209, Maharashtra, INDIATel: +91 2138 675613 Web: www.mkppl.com

E-mail id: sudha@mkppl.com Mobile: 0091 9225507296

CONTACT US