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Details
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Specifications
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CAS Number
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3008544-96-2
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Molecular Formula
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C48H48F2N10O5.1/2Ca.H2O (C6H9NO)n
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Molecular Weight
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921.02 g/mol.
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Synonyms
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-
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Chemical Name
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3-((1S, 2S)-1-(5-((S)-2, 2-dimethyltetrahydro-2H-pyran-4-yl)-2-((S)-3-(3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl)-2-(4-fluoro-3,5-dimethylphenyl)-4-methyl-4,5,6,7-tetrahydro-2H-pyrazolo[4,3-c]pyridine-5-carbonyl)-1H-indol-1-yl)-2-methylcyclopropyl)-1,2,4-oxadiazol-5(4H)-onehemi calcium hydrate Crospovidone.
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Therapeutic use
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Type 2 diabetes and obesity
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Status
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Tech pack available
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Background
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Orforglipron hemicalcium hydrate is an investigational, once-daily oral, non-peptide GLP-1 receptor agonist designed to treat Type 2 diabetes and obesity. It acts as an agonist, promoting insulin secretion and reducing body weight (up to 5.4 kg in 4 weeks) and HbA1c, without requiring special food or water restrictions.
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Grade
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In-house
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Polymorph
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Amorphous
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Storage Temperature
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Controlled temperature at 2?C ? 8?C
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
Disclaimer:
The information provided on this webpage is based on the best available knowledge at the time of publication; however, accuracy and completeness are not guaranteed. Product specifications may change without notice. It is the responsibility of the purchaser or user to verify suitability and compliance. This product is intended for research use only and is not approved for human consumption.
Orforglipron premix is a formulation-ready, co-processed intermediate of orforglipron hemicalcium hydrate (CAS 3008544-96-2) blended with the pharmacopoeial excipient crospovidone. The active component, orforglipron, is an orally active, once-daily, non-peptide glucagon-like peptide-1 (GLP-1) receptor agonist developed for the management of type 2 diabetes mellitus and obesity. As a fully synthetic small molecule, it enables convenient oral dosing without the strict food- and water-timing restrictions associated with injectable peptide GLP-1 agonists, making it one of the most significant metabolic-disease molecules of the decade.
The premix carries the molecular formula C₄₈H₄₈F₂N₁₀O₅·½Ca·H₂O·(C₆H₉NO)ₙ, where (C₆H₉NO)ₙ denotes crospovidone, with the active orforglipron hemicalcium hydrate contributing a molecular weight of 921.02 g/mol. Supplied in the amorphous form, the premix is engineered to support content uniformity, dissolution, and downstream processability during oral solid dosage development. As the molecule advances into its first global regulatory approvals, demand for reliable orforglipron premix manufacturers and suppliers has accelerated sharply across regulated and emerging markets.
Shilpa Pharma Lifesciences is among the leading orforglipron premix manufacturers in India, supplying this formulation-ready intermediate to pharmaceutical and biotechnology partners worldwide. Backed by a complete technical package and integrated CDMO capabilities, Shilpa Pharma supports global partners from early development through commercial-scale manufacturing and supply.
Orforglipron premix is supplied as a formulation-ready intermediate for use by pharmaceutical and biotechnology manufacturers in the development and production of oral anti-diabetic and anti-obesity solid dosage forms. By co-processing the active orforglipron hemicalcium hydrate with crospovidone, the premix is designed to aid uniform active distribution, promote disintegration and dissolution, and simplify the downstream tableting or encapsulation of a low-dose, amorphous active.
In a development and manufacturing context, the premix supports oral solid dosage (tablet and capsule) development, content uniformity and blend-homogeneity optimisation, dissolution enhancement, analytical method development and validation, stability studies, and scale-up to clinical and commercial supply. For partners developing orforglipron finished dosage forms, the premix can shorten formulation timelines and reduce processing complexity compared with handling the neat active alone.
As established orforglipron premix suppliers, Shilpa Pharma provides material exclusively to qualified pharmaceutical manufacturers, biotechnology companies, and international trading partners for development and manufacturing use under applicable regulatory frameworks.
As a member of the GLP-1 receptor agonist class, the active orforglipron’s clinical safety and tolerability profile is broadly consistent with the established GLP-1 class. In clinical studies, the most commonly reported adverse effects have been gastrointestinal, including nausea, vomiting, diarrhoea, constipation, and dyspepsia; these are typically mild to moderate, dose-dependent, and most frequent during dose escalation. Consistent with the class, finished-product labelling carries class-related precautions, including a boxed warning regarding the risk of thyroid C-cell tumours observed in rodent studies. Concomitant use with other GLP-1 receptor agonists is not recommended.
Crospovidone, the co-processed excipient in the premix, is a widely used, pharmacopoeial-grade disintegrant with a well-established safety record in oral solid dosage forms. From a handling and occupational-safety standpoint, orforglipron premix should be handled by trained personnel using appropriate engineering controls and personal protective equipment in accordance with the product’s Safety Data Sheet (SDS). The premix should be stored under controlled refrigerated conditions at 2°C to 8°C, protected from moisture and light, to maintain stability and quality.
This information is provided for scientific and technical reference to pharmaceutical professionals and does not constitute medical advice.
The cost of orforglipron premix varies according to order volume, required specifications, premix composition, packaging, documentation, and delivery destination. As bulk pricing is project- and quantity-specific, Shilpa Pharma does not publish standard list pricing for this product.
For current orforglipron premix pricing, bulk quantity cost estimates, and commercial supply terms, pharmaceutical and biotechnology buyers are invited to contact Shilpa Pharma directly. As trusted orforglipron premix suppliers and exporters, our team provides a tailored quotation based on your required quantity, grade, premix specification, and regulatory documentation needs, along with competitive, cost-effective supply options for both development-scale and commercial-scale requirements.
Shilpa Pharma Lifesciences is one of the most trusted orforglipron premix manufacturers in India and a full-scale CDMO partner, supplying high-quality active pharmaceutical ingredients and formulation-ready intermediates to pharmaceutical and biotech companies across more than 80 countries. For orforglipron premix, partners choose Shilpa Pharma for:
Partner with Shilpa Pharma, a trusted orforglipron premix manufacturer and exporter, for a dependable, scalable, and cost-effective global source of this formulation-ready intermediate.
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*