ACTIVE PHARMACEUTICAL INGREDIENTS
The Leading Bulk API Sourcefor Your Pharmacy Compounding Requirements
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
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
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
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
•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
•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
•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
•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
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
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.
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
Thanks for your attention !