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Somatropin recombinant manufacturers

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Country of origin : China

1 products found

somatropin recombinant

Solution for injection, cartridge 5 mg/1.5 ml, 10 mg/1.5 ml

Manufacturer usually replies in 4 business days

Dossier type

CTD

Dossier status

Ready to file

Country of origin

China

GMP approvals

EU GMP, China

Unavailable markets

Bahrain

, Iraq

, Kuwait

, Oman

, Qatar

, Saudi Arabia

, United Arab Emirates

Comments

EU market on evaluation

Manufacturer #22243

This CTD dossier owner and manufacturer specializes in pharmaceutical research and development, regulatory registration, trading, and industrial investment. Their product portfolio encompasses chemical generic drugs (including APIs), biological products, and plasma products. Key therapy areas include central nervous system disorders, diabetes, infectious diseases, and cardiovascular conditions. They offer a range of dosage forms including tablets, injections, and intermediates.The company serves customers across the EU, North America, and other regions through a global network. Their commitment to quality is demonstrated by their adherence to Good Manufacturing Practices (GMP) certifications. They hold several patents for their products and provide services such as regulatory affairs consultation and technology transfer.

Manufacturer usually replies in 4 business days

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About somatropin recombinant

Somatropin recombinant manufacturers include Novo Nordisk (Norditropin), Pfizer (Genotropin), Eli Lilly (Humatrope), Merck KGaA (Saizen), Ferring (Zomacton), Sandoz (Omnitrope, the first biosimilar) and GeneScience in China. Somatropin is recombinant human growth hormone, identical to the hormone made by the pituitary gland. It is used to treat growth failure in children and growth hormone deficiency in adults. Pharmaceutical companies can source somatropin injections, biosimilar dossiers and drug substance through out-licensing, supply or technology transfer.

Somatropin recombinant key facts

Property	Somatropin recombinant
INN	Somatropin
Molecule type	Recombinant human growth hormone, 191 amino acids, about 22 kDa
ATC code	H01AC01
Drug class	Growth hormone (somatotropin)
Main brands	Norditropin (Novo Nordisk); Genotropin (Pfizer); Humatrope (Eli Lilly); Nutropin (Genentech / Roche); Saizen (Merck KGaA); Zomacton (Ferring); Omnitrope (Sandoz)
Long-acting form	Lonapegsomatropin (Skytrofa, Ascendis Pharma), a once-weekly prodrug of somatropin
Dosage forms	Powder and solution for subcutaneous injection; cartridges, prefilled pens and needle-free devices
Paediatric indications	Growth hormone deficiency; Turner syndrome; Prader-Willi syndrome; children born small for gestational age; chronic kidney disease; SHOX deficiency; Noonan syndrome; idiopathic short stature (US)
Adult indication	Adult growth hormone deficiency
First recombinant approval	US FDA, 1985
First biosimilar	Omnitrope (Sandoz), EU, April 2006
Generic / biosimilar status	Several biosimilars approved in the EU and other markets

Somatropin recombinant manufacturers and licensing history

Recombinant growth hormone replaced growth hormone extracted from human pituitary glands in 1985, after cases of prion disease linked to the extracted product. Genentech's somatrem was first, followed by somatropin products from Eli Lilly, Pfizer, Novo Nordisk, Merck KGaA and Ferring.

In April 2006, Sandoz's Omnitrope became the first biosimilar approved in the EU under the new biosimilar pathway. In China, GeneScience Pharmaceuticals is a major producer, including a long-acting PEGylated form. Ascendis Pharma's lonapegsomatropin (Skytrofa) is a once-weekly prodrug that releases somatropin.

Somatropin is produced in E. coli or mammalian cells. Buyers should confirm the expression system, purity and isoform profile, device compatibility, GMP status and biosimilar comparability data before choosing a partner.

Somatropin recombinant dosage forms and dossier types

Somatropin is supplied as powder or solution for subcutaneous injection, usually in cartridges for pen devices.

Form	Strengths	Typical dossier	Notes
Somatropin solution in cartridges / pens	E.g. 5, 10, 15 mg (product-specific)	EU biosimilar (Art. 10(4)); US BLA / 505(b)(2) historical	Main form for licensing
Somatropin powder for injection	Per product	EU biosimilar; national	Reconstitution needed
Somatropin drug substance	Bulk	Biologics master file	E. coli or mammalian cells

Target market	Dossier format	Key requirement
European Union	Biosimilar MAA	Comparability to reference; device data
United States	BLA (biosimilar 351(k))	Interchangeability considerations
China, Asia, Latin America	National biologic dossier	Local clinical data often required

Somatropin recombinant regulatory and patent status

Recombinant somatropin was first approved in the US in 1985. Basic patents expired long ago, and several biosimilars have been approved since Omnitrope in the EU in April 2006. Device and formulation patents may still apply to specific products. In the US, somatropin products moved to the biologics framework in 2020.

Somatropin recombinant mechanism of action and therapeutic use

Somatropin binds growth hormone receptors and stimulates the liver and other tissues to produce insulin-like growth factor 1 (IGF-1). This drives bone growth in children and helps regulate body composition and metabolism in adults. Somatropin is injected daily, or weekly for long-acting forms, to treat growth failure in children and growth hormone deficiency in adults.

Somatropin recombinant licensing and sourcing

Somatropin suppliers and licensing partners typically offer biosimilar dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status, comparability data, device format and territory availability. Current offers and supplier contacts are listed among the somatropin recombinant manufacturers on Pipelinepharma.

Frequently asked questions about somatropin recombinant

Who are the main somatropin manufacturers? Novo Nordisk, Pfizer, Eli Lilly, Merck KGaA, Ferring and Sandoz are major producers. GeneScience is a leading producer in China.

Is there a biosimilar somatropin? Yes. Sandoz's Omnitrope became the first EU biosimilar in April 2006, and several others have since been approved.

What is somatropin used for? Somatropin treats growth failure in children, including growth hormone deficiency and Turner syndrome, and growth hormone deficiency in adults.

What forms of somatropin are available? Somatropin is available as powder or solution for subcutaneous injection, mostly in cartridges or prefilled pens.

What is long-acting growth hormone? Long-acting forms, such as lonapegsomatropin, are injected once weekly instead of daily. Other weekly products, such as somapacitan and somatrogon, are modified growth hormone molecules.

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