Orforglipron premix

Category
Details
Specifications
CAS Number
3008544-96-2
Molecular Formula
C48H48F2N10O5.1/2Ca.H2O (C6H9NO)n
Molecular Weight
921.02 g/mol.
Synonyms
-
Chemical Name
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.
Therapeutic use
Type 2 diabetes and obesity
Status
Tech pack available
Background
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.
Grade
In-house
Polymorph
Amorphous
Storage Temperature
Controlled temperature at 2?C ? 8?C

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:

  • Regulatory-ready manufacturing: produced at cGMP-compliant facilities supported by approvals from USFDA, EU GMP, PMDA, TGA, ANVISA, COFEPRIS, and KFDA.
  • Formulation-ready intermediate: a co-processed premix designed to aid content uniformity, dissolution, and downstream processability, helping to accelerate oral solid dosage development.
  • Complete technical package: a ready tech pack that accelerates partner evaluation, formulation development, and regulatory filings.
  • Integrated CDMO capability: end-to-end support from active and premix development to analytical characterisation and commercial-scale supply, including customised premix specifications.
  • Solid-state and analytical expertise: amorphous-form control, impurity profiling, and method development for consistent, formulation-ready quality.
  • Reliable global supply: scalable capacity with established export, logistics, and documentation infrastructure, positioning Shilpa Pharma among dependable orforglipron premix suppliers and exporters for regulated and emerging markets.
  • Confidentiality and partnership: IP-sensitive, transparent collaboration backed by decades of API manufacturing expertise.

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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Questions & Answers

FAQ on Orforglipron premix

Everything You Need to Know About Shilpa Pharma

Orforglipron received its first US FDA approval in April 2026 as the originator’s once-daily oral GLP-1 product. As an innovator molecule, it remains under patent protection, so commercial generic supply depends on patent expiry and exclusivity in each market. Shilpa Pharma supplies orforglipron premix to qualified partners for development, evaluation, and regulatory-readiness purposes under applicable laws, positioning them for future commercial supply.
The API (orforglipron hemicalcium hydrate) is the neat active substance, whereas the premix is the same active co-processed with crospovidone into a formulation-ready intermediate. The premix is designed to aid content uniformity, disintegration, and dissolution, simplifying downstream tablet or capsule development compared with handling the low-dose active alone.
Crospovidone is a pharmacopoeial superdisintegrant that promotes rapid wetting, disintegration, and drug release. In the orforglipron premix, co-processing the amorphous active with crospovidone supports uniform active distribution and consistent dissolution, which is especially valuable for a low-dose, poorly water-soluble molecule.
Orforglipron is a low-solubility small molecule, which is why it is supplied in the amorphous form. The premix combines this amorphous active with crospovidone to support faster dissolution and reproducible release, helping formulators improve the dissolution performance of the finished oral dosage form.
Many developers source innovator molecules early for research, formulation development, and regulatory dossier preparation under research-use and Bolar-type provisions that exist in several markets. Shilpa Pharma, as one of the leading orforglipron premix manufacturers in India, supplies the premix to qualified pharmaceutical manufacturers for such development use under applicable regulations; buyers should confirm the patent position in each target territory.
A complete technical package is available now to support evaluation and formulation development. As the program advances toward commercial supply, Shilpa Pharma provides full regulatory documentation support, including Drug Master File and CEP preparation as required, drawing on facilities approved by USFDA, EU GMP, PMDA, TGA, ANVISA, COFEPRIS, and KFDA.
Shilpa Pharma Lifesciences is among the leading orforglipron premix manufacturers in India and global exporters, supplying the premix to pharmaceutical and biotech partners worldwide. Material is offered to qualified manufacturers, biotech companies, and international trading firms for development and manufacturing use.
Yes. Shilpa Pharma’s cGMP-compliant facilities hold approvals for major regulated markets, and the company supplies orforglipron premix with supporting documentation to partners across the USA, Europe, Japan, and 80+ countries, subject to the applicable regulatory and patent considerations in each market.
Lead time and minimum order quantity depend on the requested quantity, premix specification, and documentation needs, and minimum order quantities apply. As trusted orforglipron premix suppliers and exporters, Shilpa Pharma provides a tailored quotation and timeline once your requirements are shared.
Yes. Through its integrated CDMO services, Shilpa Pharma can support the full pathway from active and premix development to finished oral solid dosage development, analytical characterisation, and commercial-scale supply, including customised premix specifications, all under a single regulatory umbrella.

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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*