LYOTEX is the world´s first-choice supplier of peptides used as pharmaceutical agents with a range of more than 100 peptides and related products, from grams to kgs, generic standard to cGMP (current Good Manufacturing Practice) standard. As a reliable partner for APIs manufacture, we have served a great many of customers by providing qualified APIs for their projects. Now they are broadly used in the fields of cancer, cardiovascular and diabetes research, etc.
APIs is also known as bulk pharmaceuticals, and the peptides used as APIs take a special vital role in the pharmaceutical industry. Only the good management of API peptides synthesis can better serves the pharmaceutical industry as well as the human health.
Regulation of Therapeutic Peptides
In 2013, the US Pharmacopeia (USP) Therapeutic Peptides Expert Panel was established to assess quality attributes for synthetic peptide APIs based on currently available regulatory direction and expectations. According to the panel explores the current manufacturing and regulatory landscape that bring out three articles as below. These articles provide a comprehensive overview of quality attributes to be considered for successful synthetic peptide APIs development from manufacturing to lot release.
- The first article was described analytical characterization methods, lot-release tests and points to consider for synthetic peptide APIs manufacturers entering the market.
- The second article covered raw materials used in the chemical synthesis of peptides and their potential influence on the quality attributes of the final APIs. A special focus of this article will be on guarded amino acid derivatives, setting their specifications and types of quality control tests necessary to ensure consistent quality of the final APIs.
- The last article is concentrated on manufacturing process and impurity control for synthetic peptide APIs.
USP hopes that the work of the Therapeutic Peptides Expert Panel and those articles will offer more constant management to help support efforts to create a maintainable platform for the development of peptide-based drugs.
Why choose to prefer Lyotex ?
With years of extensive experience on APIs manufacture, Lyotex is able to provide comprehensive support for all stages of APIs development and production. With the advanced technologies and innovative methodologies, your unique requirement can be satisfied. Below is a list of the API peptides we are currently offering. If you have any request for API peptides synthesis, please feel free to contact us. Our sales team will generate a quote for you with price and delivery time at their first available moment.Lyotexoffers a variety of generic peptides used as active pharmaceutical ingredients (APIs). These generic peptides are utilized to treat a variety of diseases including cancer, diabetes, obesity, and multiple sclerosis. Our GMP manufacturing facility employs a rigorous quality and EHS system to insure global compliance, including the stringent requirements of the United States, European Union, China, India and Japan. In addition, we fully support our pharmaceutical customers with required regulatory documentation including Drug Master Files (DMFs). Below is a listing of generic peptides that we currently provide.
AVAILABLE GENERIC PEPTIDES:
- Eptifibatide acetate
- Exenatide acetate
- Glatiramer acetate
- Glucagon acetate
- Glucagon hydrochloride
- Glucagon-like peptide
- GLP-1 (7-36) amide Acetate
- Octreotide Acetate
- Carbetocin Acetate
- Gonadorelin acetate
- Goserelin acetate
- Leuprolide acetate
- Lysipressin acetate
- Melanotan-II acetate
- Nesiritide acetate
- Octreotide Acetate
- Oxytocin acetate
- Degarelix Acetate
- PTH (1-34)
- Salcitonin acetate
- Secretin acetate
- Sermorelin acetate
- Somatostatin acetate
- Teriparatide acetate
- Terlipressin acetate
- Thymosin α1 acetate
- Triptorelin acetate
- Ziconotide acetate
- Leuprolide Acetate
Hormone therapy drug used to treat prostate cancer. Leuprolide is a nonapeptide GnRH (LHRH) analog that stops the pituitary gland from producing luteinizing hormone. This action leads to a reduction in testosterone levels, which may help to shrink the tumor or slow its growth.
Prevents the production of certain types of hormones in the body. Triptorelin is a decapeptide GnRH (LHRH) agonist used to treat men with prostate cancer, women who have uterine fibroids or endometriosis, and boys and girls when puberty occurs prematurely.
Decreases blood flow to the gastrointestinal system and can help reduce gastrointestinal bleeding caused by high blood pressure in the liver or swollen blood vessels in the esophagus. Terlipressin is an analog of the peptide hormone, vasopressin, used as a vasoactive drug in the management of hypotension.
A glucagon-like peptide (GLP)-1 receptor agonist used for the treatment of type 2 diabetes and obesity. It works by increasing the amount of insulin produced by the body. It also helps decrease sugar levels produced by the liver and absorbed by the intestines.
Buserelin is a gonadotropin-releasing hormone agonist (GnRH agonist). Interactions of buserelin with GnRH causes immediate release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) by gonadotrophes.
Exenatide is an injectable drug that reduces the level of glucose in the blood and is used to treat type 2 diabetes. It is a 39-amino acid peptide that resembles and acts like GLP-1, which the action of glucagon, and reduces appetite.Glatiramer Acetate. Glatiramer is an immunomodulator drug used to treat multiple sclerosis in cases when there have been relapses followed by periods of recovery. It is a random polymer of four amino acids found in myelin basic protein that works by preventing the body from damaging nerve cells.
A long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Octreotide reduces blood levels of growth hormone (GH) and insulin-like growth factor (IGF-1) in acromegaly patients. Octreotide is also used to control symptoms such as diarrhea or flushing in patients with carcinoid tumors, pancreatic islet cell tumors, gastrinoma, or vasoactive intestinal peptide-secreting tumors (VIPomas).
Glucagon, a single-chain polypeptide containing 29 amino acid residues, is a peptide hormone that increases blood glucose concentration and is used in the treatment of hypoglycemia. It acts only on liver glycogen, converting it to glucose. Glucagon relaxes smooth muscle of the stomach, duodenum, small bowel, and colon.
Bivalirudin is a 20 residue peptide (direct thrombin inhibitor) that reversibly inhibits thrombin. It is used in patients who are having certain heart and blood vessel procedures, such as coronary angioplasty. Bivalirudin decreases the blood’s clotting ability, which helps prevent harmful blockages from forming in blood vessels.
A cyclic hexapeptide that binds to platelet receptor glycoprotein and inhibits platelet aggregation. Eptifibatide keeps the platelets in the blood from coagulating (clotting) to prevent blood clots or heart attack for those with severe chest pain or other conditions, and for those undergoing angioplasty to open blocked arteries.
Developing peptides to your exact specifications. Don’t see the generic API that you are looking for? Please let us know so that we can discuss peptides that will meet your particular needs. We are your peptide partners from concept to commercial.