• Our PTH material is produced in compliance with GMP guidelines and undergoes rigorous quality testing, including:
• Purity and identity verification (HPLC, Mass Spectrometry)
• Endotoxin testing (LAL assay)
• Sterility and microbial contamination screening
• Manufactured under cGMP guidelines
• Complies with USP, EP, and JP standards
• Endotoxin and sterility tested
• DMF available upon request
• Comprehensive CMC documentation for regulatory submissions
• Compliance with CDSCO, EMA, and ICH guidelines
• Stability studies as per regulatory requirements
• cGMP, CDSCO, EMA, and ICH guidelines.
• Manufactured in cGMP-compliant facilities
• Stringent quality control and batch-to-batch consistency
• Regulatory support available for global market approvals
• Lorven manufactured following strict cGMP guidelines and in compliance with CDSCO and EMA regulations.
• Produced under cGMP-compliant facilities.
• Meets regulatory standards such as CDSCO, and EMA.
• Free from animal-derived components and prion contamination.
• Tapentadol was first approved for the US market in 2008. The safety and efficacy data of tapentadol for the treatment of acute and chronic pain in adults has been well established
• Sitagliptin was approved by the US Food and Drug Administration (FDA) in October 2006, and is sold under the brand name Januvia. In April 2007, the FDA approved an oral combination of sitagliptin/metformin sold under the brand name Janumet.
• Phenylephrine received FDA approval for over-the-counter use in the 1970s, its popularity surged in 2005 after legislation moved products that use a similar decongestant, pseudoephedrine.
• Apixaban is a novel oral anticoagulant approved by the US Food and Drug Administration (FDA) in 2012 for use in patients with nonvalvular atrial fibrillation to reduce the risk of stroke and blood clots.
• Pregabalin was approved by the United States Food and Drug Administration (FDA) in 2004. Pregabalin is utilized for neuropathic pain and seizures.
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