See our different product offerings below:
We constantly aim to provide our clients with APIs coupled with complete technical and regulatory documentation
(TDP / CTD / E-DMF / CEP / US-DMF etc…). Our APIs originate from EU-GMP certified and US-FDA approved production facilities.
Our supported Therapeutic Classifications include:
As an R&D driven company, LGM Pharma focuses on developing API supply solutions that enable us to support our clients throughout the entire research and development pathway – from discovery till market.
Based on your specific requirements, we can provide cost effective materials for your initial research, POC and preclinical development work.
Be it an NCE, a Biosimilar, a Monoclonal Antibody, a rare Protein or an API that is still in Phase II
testing – LGM Pharma can provide you with samples towards your research use !
LGM Pharma provides cGMP APIs along with a complete package of technical documentation and regulatory support
for all clinical trial phases.
LGM’s goal is to help you move quickly and efficiently from preclinical development into clinical trials.
LGM Pharma has extensive knowledge and experience providing clients with suitable APIs,
accompanied by adequate regulatory accreditation, technical support and CMC/DMF documentation
LGM Pharma provides commercial bulk quantities of cGMP APIs based on our clients’ specific
requirements. We possess unparalleled competitive intelligence on API resources and pharma market
positioning.
We are committed to maintaining the highest standards of regulatory compliance. Our manufacturing partner sites are fully accredited and certified by all major
regulatory authorities (US-FDA, EDQM, TGA, MHRA, PMDA, ANVISA, COFEPRIS etc…). We are ready to
facilitate the most stringent API specifications for your finished dosage forms.
The products listed below are a sampling of the OTC APIs that are presently available from LGM Pharma:
All of our OTC APIs come in original manufacturer packaging and original manufacturer labels. Please ask us for any
available type of technical or regulatory documentation, including : Certificates of Analysis, MSDSs, GMP certificates,
Allergen statements, GMO statements, Kosher / Halal Certifications etc..
LGM Pharma has close to 20 years of experience in supplying suitable APIs to the major repackaging distributors who cater to the US compounding industry.
If you require a product that is not on this list, it would be our pleasure to support you with your requirements.
Compounding pharmacies are welcome to contact one of the major repackaging distributors for any specific API
requirements.
The area that excites LGM more than anything is working with other innovation driven companies that are focused around various drug delivery technologies.
Nasal devices, fast dissolving film strips, sublingual spray, microscopic ophthalmic stents, topical patches and orally disintegrating tablets are all amazing drug delivery technologies that our business development team is involved with regularly.
We supply APIs that are tailor-made to suit your application. We work to solve your challenge – API solubility, nano particle size, taste masking etc – our dedicated team has years of experience dealing with these same technical issues. Below is a concise listing of APIs sorted by different drug delivery applications:
Inhalation
Ophthalmic
Transdermal
Sublingual
Injectable