LGM Pharma | The Leading Bulk API Source for Pharmacy Compounding

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ACTIVE PHARMACEUTICAL INGREDIENTS The Leading Bulk API Source for Your Pharmacy Compounding Requirements

description

LGM Pharma has over 15 years of experience supplying quality Bulk Active Ingredients to distributors, re-packers and the U.S. pharmacy compounding industry. Our extensive knowledge and experience in the Bulk Active Ingredients market means we’re always on top of the latest news, regulations, innovations, and drugs the market as to offer. We comply with current FDA and CVM rulings and regulations, and supply from FDA registered sources with valid NDC numbers. LGM Pharma is the exclusive TAPI distributor to the US pharmacy compounding industry. In continuation with our efforts to supply only the finest quality API's to our clients while minimizing any regulatory problems and quality issues, LGM Pharma was selected in Aug 2009 as the sole distributor of Teva for their extensive API portfolio. *Please note that LGM Pharma primarily sells bulk quantities of active pharmaceutical ingredients (APIs) to main distributors for the U.S. pharmacy compounding industry. LGM Pharma does in engage in any repackaging activities and does not actively solicit compounding pharmacies. We request that pharmacies please direct their inquiries to the distributors and re-packers.

Transcript of LGM Pharma | The Leading Bulk API Source for Pharmacy Compounding

Page 1: LGM Pharma | The Leading Bulk API Source for Pharmacy Compounding

ACTIVE PHARMACEUTICAL INGREDIENTS

The Leading Bulk API Sourcefor Your Pharmacy Compounding Requirements

Page 2: LGM Pharma | The Leading Bulk API Source for Pharmacy Compounding

Over 15 Years of Experiencein Supplying API’s to the

US Pharmacy Compounding Industry

LGM Pharma supplies bulk API’sto all of the major repackaging distributors

who cater to the US pharmacy compounding industry.

APIS FOR COMPOUNDING

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COMPOUNDING EXPERIENCE

LGM Pharma has extensive knowledge andexpertise in supplying suitable products

to the US pharmacy compounding market.

•LGM follows the latest FDA & CVM rulings and regulations•LGM supplies API's only from GMP certified & FDA registered factories with

full transparency•LGM visits and audits all major global suppliers and manufacturers

•LGM maintains excellent relationships with all main API supply sources & follows closely after the pricing trends for the pharma industry

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LOGISTICAL CAPABILITIES

Accurate Shipment Paperworkincluding all necessary details

Precise Product Labelingas per latest GMP & FDA stipulations

Extensive Global Logistics Coverage-Global logistic centers in Europe, China & India

-Unique forwarding networks throughout all major cities

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Significant Advantages Over Competition:

•Supplying superior quality API’s as per current EP / USP demands from leading cGMP certified and US-FDA registered manufacturers

•API’s provided with original manufacturer labels and NDC details with full transparency

•US regulatory agent for several API manufacturers from China & India. Well prepared for new GDUFA regulations

•Excellent documentation level and after-service

COMPOUNDING ADVANTAGES

Page 6: LGM Pharma | The Leading Bulk API Source for Pharmacy Compounding

•Global sourcing office located in Israel with branch offices in Shenzhen, China and in Mumbai, India

•All API sourcing operations are performed from outside US only, ensuring most competitive pricing and quickest service

•Close relationships with all API inventory holdersin Europe, ensuring continuous supply even during

product shortages

COMPOUNDING ADVANTAGES

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•GMP compliant storage facilities in Florida, New Jersey and California, giving immediate responses for your JIT requirements.

•Holding over 50 API’s regularly in stock

•Retaining the regulatory consulting services of FDA legal attorneys for import advice and expert assistance

•Personal factory quality audits throughout China and India

•Employing fully qualified, well educated and trained staff

COMPOUNDING ADVANTAGES

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•CPhI Worldwide (Europe, China & India)•API Fair (China) and Chemspec (Europe & India)

•Informex, Bio International & DCAT (USA)

Held every year in major global destinations, these events are unrivalled in their ability to bring together every facet of the business

LGM sourcing managers are always present at every international API tradeshow, in order to ensure that LGM clients get the full benefit of cutting

edge information on competitive pricing, product availability, innovative technologies and pharmaceutical market trends

INTERNATIONAL EXHIBITIONS

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•Proper knowledge of current EP / USPmonograph requirements

•Particle size provided as per client requirement for anyend application

•Expert identification & troubleshooting of any quality issues for each individual product

•Professional documentation and post-shipment service

QUALITY ASSURANCE

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LGM Pharma is theexclusive TAPI distributor

to the US pharmacycompounding industry

In continuation with our efforts to supply only the finest quality API's to our clients while

minimizing any regulatory problems and quality issues, LGM Pharma was selected in Aug 2009

as the sole distributor of Teva for their extensive API portfolio

TEVA API DIVISION

Page 11: LGM Pharma | The Leading Bulk API Source for Pharmacy Compounding

Teva API division (TAPI) manufactures over 300 different API's covering various therapeutic categories, and have registered DMF's

and CEP’s for all products. TAPI group factories include well known names in the global pharmaceutical landscape, such as

IVAX (Czech Rep), Sicor (Italy), Pliva (Croatia), PFC (Italy) and more.

TEVA API DIVISION

• TAPI are widely recognized as the world-leader in terms of their API production, excellent GMP quality assurance and extensive regulatory position.

• All TAPI factories are fully regulated and approved by global regulatory authorizations such as the US-FDA, EDQM, MHRA, TGA, PMDA and others.

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Acyclovir

Altrenogest

Azithromycin

Baclofen

Chloramphenicol

Palmitate

Clarithromycin

Cyclosporine

Deslorelin Acetate

Fluconazole

Flunixin Meglumine

Gabapentin

GHRP-2 & GHRP-6

Isoxsuprine HCL

Itraconazole

Liothyronine Sodium

Metronidazole Base &

Benzoate

Naltrexone Base & HCL

Pentosan Polysulfate

Sodium

Pentoxifylline

Pergolide Mesylate

Phenylbutazone

Sermorelin Acetate

Sulfadiazine Base &

Sodium

Toltrazuril

Trichlormethiazide

Trilostane

Ursodiol

Vancomycin

MAIN APIS FOR COMPOUNDING

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Thanks for your attention !