Penmix presentation 20170112

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COMPANY OVERVIEW

PENMIX Your challenge, Our solution


Quick Facts • Annual Revenue : 46 Million USD (2015) +22% from 2014 • Field of Business

Penicillin Products General Injectables

CDMO

• Facilities

Factory 1: Penicillin specialized -

Largest capacity in Korea

-

Oral (tablet, Syrup) / Injectable (powder-filled, lyophilized vials)

Factory 2 : General Injectable -

Established in late 2013 with EU GMP, cGMP level

-

Lyophilized, Vials, PFS, Big vials, Powder

• Key Characteristics / Experiences -

NO. 1 Penicillin Manufacturer / supplier in Korea NO. 1 in Penicillin Injectables supplier in Japan (generic) Exports to +14 countries world wide

+10 years of Experience w/ Injectables (Lyophilized, vials)


HISTORY 2002 Separated from its parent Company Kuhnil pharma. Established its Headquarters in Korea.

2010 Designed concept for the new injectable plant (EU / cGMP grade)

Awarded for “Large and Small business Cooperation� by the Prime Minister

2004

2006

2008

Introduced equipment for injectable line with expansion of the factory.

Second expansion of the factory with additional equipment for the injectable line

Expanded export to Japanese market

Further expansion of the export to the Japanese market

2011

2013

Established the automated warehouse

Completed Injectable Factory construction

Initiated Injectable Factory construction .

GMP certification Approval for Injectable Factory by KFDA

Introduced Equipment for Solid dosage form production Award for achieving 10 million USD in Export

2014 Completed PreFilled Syringe line. Manufacturing initiated for General Inj. Factory


COMPANY OVERVIEW PENMIX = PENICILLIN + MIXTURE Specialized in manufacturing Penicillin and General Injectable Products as a CDMO

Penicillin

GENERAL INJECTABLE

▶ Specialized in finished penicillin products • Oral : Tablet, Dried Suspension • Injectable : Lyophilized, Powder filled Vial ▶ Approved by Japan as a foreign manufacturer

▶ Manufacturing facility established in 2013 • EU GMP, cGMP grade • KGMP Approval in November 2013 ▶ Capable of manufacturing Ampoule, Vial and PFS


Key Business Scope


The View of the Plants PENMIX

Penicillin Dedicated Factory

KUHNIL Pharm. Factory

PENMIX

General Injectable Factory


Manufacturing Capacity General Injectable Factory Production Line

Units

Lyophilizer 1 (300kg) Freeze dried (Lyophilized)

Lyophilizer 2 (500kg)

Vial (22Ø)

Lyophilizers 3 & 4 (600kg)

Current Annual Production Capacity Batch

Vial / Ampule / PFS

80

2,400,000

80

4,800,000

100

7,200,000

Powder

Vial (22Ø)

200

10,000,000

Ampoule

1mL Ampoule (11.2 Ø)

200

19,200,000

PFS

5mL Syringe (High Viscosity)

100

10,000,000 (5,000,000)

Penicillin Factory Production Line

Solids

Units

Current Annual Production Capacity Batch

Tablet / Bottle / Vial

Tablet

Tablet

600

300,000,000

Suspension

50mL Bottle

275

11,000,000

Powder

Vial (24Ø)

480

19,200,000

Lyophilized

Vial (24Ø)

162

6,480,000


Pipeline


GENERAL INJECTABLE Development schedule (tentative)

Anidulafungin Daptomycin (US)

Formulation study completed Formulation study in-progress

Glatiramer Micafungin Octreotide LAR Remifentanil Caspofungin Hyaluronic Acid

Glutathione Teicoplanin (KR) 2014

Vancomycin 2015

Dexmedetomidin

Palonosetron

Tigecycline(KR)

Voriconazole

2016

2017

Icatibant Paliperidone Teicoplanin (EU) 2018 and forward


Thank you. PENMIX Contact us at : Website: www.penmix.com Email : pexmixmail@kuhnil.com


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