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Sermorelin API Manufacturers & Suppliers

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Commercial-scale Suppliers

Producer
Produced in  China
|

Employees: 10+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: MSDS
|
BSE/TSE
|
CoA

All certificates

MSDS
BSE/TSE
CoA
Producer
Produced in  China
|

Employees: 250+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
MSDS
|
BSE/TSE
|
CoA

All certificates

GMP
MSDS
BSE/TSE
CoA
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Distributor
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: FDA
|
MSDS
|
CoA

All certificates

FDA
MSDS
CoA
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Sermorelin | CAS No: 86168-78-7 | GMP-certified suppliers

A medication that supports treatment of growth disorders linked to dwarfism and helps prevent HIV‑associated weight loss by promoting healthy anabolic balance.

Therapeutic categories

Amino Acids, Peptides, and ProteinsAnterior Pituitary Lobe Hormones and AnaloguesDiagnostic AgentsGrowth Hormone-Releasing HormoneHormonesHormones, Hormone Substitutes, and Hormone Antagonists
Generic name
Sermorelin
Molecule type
biotech
CAS number
86168-78-7
DrugBank ID
DB00010
Approval status
Approved drug, Withdrawn drug
ATC code
V04CD03

Primary indications

  • For the treatment of dwarfism, prevention of HIV-induced weight loss

Product Snapshot

  • Injectable peptide supplied as an intravenous powder-for-solution formulation
  • Its primary uses relate to managing growth hormone deficiency–associated dwarfism and mitigating HIV‑associated weight loss
  • It was previously approved in major markets but has since been withdrawn from regulatory use

Clinical Overview

Sermorelin acetate (CAS 86168-78-7) is an amidated synthetic peptide comprising the first 29 amino acids of endogenous growth hormone‑releasing hormone. It retains the functional domain responsible for binding to pituitary growth hormone‑releasing hormone receptors and is classified among peptide hormones, hypothalamic and pituitary hormone analogues, and diagnostic agents.

Clinically, sermorelin has been used for the evaluation and treatment of pediatric growth hormone deficiency and growth failure. It has also been described for prevention of HIV‑associated weight loss where stimulation of endogenous growth hormone secretion may provide anabolic support. Geref is a commonly cited reference product. Regulatory status varies by jurisdiction, and some historical approvals have been withdrawn.

Pharmacologically, sermorelin increases circulating growth hormone concentrations by stimulating physiologic release from the anterior pituitary. As a truncated analogue of native GHRH, it exhibits similar receptor affinity and downstream signaling, leading to pulsatile growth hormone secretion and secondary increases in insulin‑like growth factor 1.

Mechanistically, the peptide binds the GHRH receptor on somatotroph cells, activating adenylate cyclase and cyclic AMP pathways. This activation promotes synthesis and exocytosis of growth hormone while preserving endogenous feedback control.

ADME characteristics reflect those of small peptides. Absorption is via parenteral administration, followed by rapid distribution and enzymatic degradation by peptidases. The circulating half‑life is short, and elimination occurs primarily through metabolic breakdown rather than renal excretion of intact peptide. Sermorelin is not known to accumulate with repeated dosing.

Safety considerations include transient injection‑site reactions, facial flushing, and mild gastrointestinal effects. Excessive growth hormone stimulation may theoretically contribute to glucose intolerance or edema, although physiologic feedback limits sustained elevations. Use is contraindicated in individuals with known hypersensitivity to peptide components or in settings where growth hormone stimulation is inappropriate.

For API procurement, sourcing should prioritize manufacturers with robust peptide synthesis controls, validated impurity characterization, and compliance with current GMP to ensure consistency in sequence integrity, acetate content, and sterility or endotoxin limits where applicable.

Identification & chemistry

Generic name Sermorelin
Molecule type Biotech
CAS 86168-78-7
UNII 89243S03TE
DrugBank ID DB00010

Pharmacology

SummarySermorelin is a synthetic analog of growth hormone–releasing factor that activates the growth hormone–releasing hormone receptor on pituitary somatotrophs. This interaction promotes physiologic growth hormone secretion, increasing circulating GH levels. Its therapeutic intent is to address conditions associated with inadequate endogenous growth hormone production or catabolic weight loss.
Mechanism of actionSermorelin binds to the growth hormone releasing hormone receptor and mimics native GRF in its ability to stimulate growth hormone secretion.
PharmacodynamicsSermorelin is used in the treatment of children with growth hormone deficiency or growth failure. Geref increases plasma growth hormone (GH) concentration by stimulating the pituitary gland to release GH. Geref is similar to the full-length native hormone (44 residues) in its ability to stimulate GH secretion in humans.
Targets
TargetOrganismActions
Growth hormone-releasing hormone receptorHumansagonist

ADME / PK

Half-life11-12 min

Formulation & handling

  • Peptide API typically supplied as a lyophilized powder requiring reconstitution to a sterile aqueous solution for intravenous administration.
  • Sensitive to temperature and proteolytic degradation; requires cold‑chain handling and protection from repeated freeze–thaw.
  • Formulation development focuses on maintaining peptide stability (pH control, suitable buffers) and minimizing adsorption to container surfaces.

Regulatory status

Supply Chain
Supply chain summarySermorelin appears to have a single identified originator manufacturer, with additional packagers supporting downstream distribution. Branded product presence is primarily documented in the United States, with limited evidence of broad EU availability. Patent expiry for this peptide suggests that generic or non‑branded versions are already feasible and may contribute to a diversified supply chain.

Sermorelin is a type of Corticotropic hormones


Corticotropic hormones, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in regulating various physiological processes in the human body. These hormones are primarily secreted by the anterior pituitary gland and are responsible for controlling the production and release of glucocorticoids, which are essential for maintaining homeostasis and managing stress.

Corticotropic hormones are mainly comprised of adrenocorticotropic hormone (ACTH), which stimulates the adrenal glands to produce cortisol, a vital stress hormone. This hormone influences multiple bodily functions, including metabolism, immune response, and blood pressure regulation. Additionally, corticotropic hormones also play a significant role in controlling inflammation and allergic reactions.

Pharmaceutical companies often utilize corticotropic hormones as APIs to develop medications that can effectively regulate adrenal function. These medications are commonly prescribed for individuals suffering from conditions such as adrenal insufficiency, autoimmune disorders, and certain types of cancer.

By harnessing the therapeutic potential of corticotropic hormones, pharmaceutical manufacturers can develop drugs that provide relief to patients experiencing adrenal dysfunction. These APIs can be formulated into various dosage forms, including tablets, injections, and topical creams, to cater to different patient needs.

Overall, corticotropic hormones are vital pharmaceutical APIs that offer immense potential in managing adrenal disorders and related conditions. Through continued research and development, these APIs have the potential to revolutionize the treatment landscape and improve the quality of life for countless individuals worldwide.


Sermorelin (Corticotropic hormones), classified under Hormonal Agents


Hormonal agents are a prominent category of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the medical field. These substances play a crucial role in regulating and modulating hormonal functions within the body. Hormonal agents are designed to mimic or manipulate the effects of naturally occurring hormones, allowing healthcare professionals to treat various endocrine disorders and hormonal imbalances.

Hormonal agents are commonly employed in the treatment of conditions such as hypothyroidism, hyperthyroidism, diabetes, and hormonal cancers. These APIs work by interacting with specific hormone receptors, either by stimulating or inhibiting their activity, to restore the balance of hormones in the body. They can be administered orally, intravenously, or through other routes depending on the specific medication and patient needs.

Pharmaceutical companies employ rigorous manufacturing processes and quality control measures to ensure the purity, potency, and safety of hormonal agent APIs. These APIs are synthesized using chemical or biotechnological methods, often starting from natural hormone sources or through recombinant DNA technology. Stringent regulatory guidelines are in place to guarantee the efficacy and safety of hormonal agent APIs, ensuring that patients receive high-quality medications.

As the demand for hormone-related therapies continues to grow, ongoing research and development efforts focus on enhancing the effectiveness and reducing the side effects of hormonal agent APIs. This includes the exploration of novel delivery systems, advanced formulations, and targeted drug delivery methods. By continuously advancing our understanding and capabilities in hormonal agents, the medical community can improve patient outcomes and quality of life for individuals with hormonal disorders.



Sermorelin API manufacturers & distributors

Compare qualified Sermorelin API suppliers worldwide. We currently have 3 companies offering Sermorelin API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
China China BSE/TSE, CoA, MSDS229 products
Distributor
United States China CoA, FDA, MSDS7 products
Producer
China China BSE/TSE, CoA, GMP, MSDS17 products

When sending a request, specify which Sermorelin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).

Use the list above to find high-quality Sermorelin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.

Frequently asked questions about Sermorelin API


Sourcing

What matters most when sourcing GMP-grade Sermorelin?
Key considerations include confirming that the material comes from a GMP‑compliant manufacturer and that the supply chain is traceable back to the identified originator or qualified packagers. It is also important to verify complete quality documentation and consistency of manufacturing, given the limited number of upstream producers. Ensuring regulatory alignment for the intended market is necessary, especially since broad EU availability is not well documented.
Which documents are typically required when sourcing Sermorelin API?
Request the core API documentation set: MSDS (3 companies), CoA (3 companies), BSE/TSE (2 companies), FDA (1 company), GMP (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Sermorelin API?
Known or reported manufacturers for Sermorelin: Apino Pharma Co., Ltd., Hangzhou Thinheal Pharma-tech Co,.Ltd, Attix Pharmaceuticals. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Sermorelin API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Sermorelin manufacturers?
Audit reports may be requested for Sermorelin: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Sermorelin API on Pharmaoffer?
Reported supplier count for Sermorelin: 3 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Sermorelin API?
Production countries reported for Sermorelin: China (3 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Sermorelin usually hold?
Common certifications for Sermorelin suppliers: MSDS (3 companies), CoA (3 companies), BSE/TSE (2 companies), FDA (1 company), GMP (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Sermorelin (CAS 86168-78-7) used for?
Sermorelin is used to stimulate endogenous growth hormone release for the evaluation and treatment of pediatric growth hormone deficiency and growth failure. It has also been used to help prevent HIV‑associated weight loss by providing anabolic support through increased growth hormone secretion.
Which therapeutic class does Sermorelin fall into?
Sermorelin belongs to the following therapeutic categories: Amino Acids, Peptides, and Proteins, Anterior Pituitary Lobe Hormones and Analogues, Diagnostic Agents, Growth Hormone-Releasing Hormone, Hormones. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Sermorelin mainly prescribed for?
The primary indications for Sermorelin: For the treatment of dwarfism, prevention of HIV-induced weight loss. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Sermorelin work?
Sermorelin binds to the growth hormone releasing hormone receptor and mimics native GRF in its ability to stimulate growth hormone secretion.
What should someone know about the safety or toxicity profile of Sermorelin?
Sermorelin’s safety profile is mainly characterized by transient injection‑site reactions, facial flushing, and occasional mild gastrointestinal symptoms. Because it stimulates endogenous growth hormone release, excessive dosing may contribute to short‑lived glucose intolerance or edema, though physiologic feedback generally limits prolonged hormone elevation. It is contraindicated in individuals with hypersensitivity to the peptide or in conditions where growth hormone stimulation is inappropriate.
What are important formulation and handling considerations for Sermorelin as an API?
Sermorelin is typically provided as a lyophilized peptide powder that requires reconstitution with sterile aqueous diluent before intravenous use. It is temperature‑sensitive and prone to proteolytic degradation, so cold‑chain storage and avoidance of repeated freeze–thaw cycles are important. Formulation work focuses on maintaining stability through pH control, appropriate buffering, and limiting adsorption to container surfaces.
Is Sermorelin a biotech?
Sermorelin is classified as a biotech. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Sermorelin?
Sermorelin is a temperature‑ and protease‑sensitive peptide, so maintaining cold‑chain conditions and avoiding repeated freeze–thaw cycles is important. Its stability depends on controlled pH, appropriate buffers, and limiting adsorption to container surfaces. These inherent peptide sensitivities would also be relevant when considering any oral use.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Sermorelin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Sermorelin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Sermorelin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Sermorelin: 4 verified transactions across 3 suppliers and 3 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Sermorelin?
Market report availability for Sermorelin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.