Carglumic Acid API Manufacturers & Suppliers in India

Carglumic acid API is a drug used to treat hyperammonemia in patients with a deficiency in N-acetyl glutamate synthase. This rare genetic disorder results in elevated blood levels of ammonia, which can eventually cross the blood–brain barrier and cause neurologic problems, cerebral edema, coma, and death. Carglumic acid was approved by the U.S. Food and Drug Administration (FDA) on 18 March 2010.

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Product Description

Product Description

Generic Name: Carglumic acid

Chemical Name : (2S)-2-(carbamoylamino)pentanedioic acid

CAS Number : 1188-38-1

Molecular weight:190.15 g/mol

Molecular formula: C6H10N2O5

Therapeutic use:  Used to treat and prevent hyperammonemia

Form: Powder

Color: White to off-white

Size of package: As per requirement

Synonyms: N-carbamyl-L-glutamic acid, (S)-2-ureidopentanedioic acid, Ureidoglutaric acid

Solubility: Sparingly soluble in water, practically insoluble in methanol

Carglumic Acid API Specification

  • ☐ Total impurities: Not more than 0.5%
  • ☐ Any unspecified impurity: Not more than 0.1%
  • ☐ Assay by HPLC (On dried basis): Not less than 98.0% w/w and not more than 102.0% w/w

Quality Standards and Manufacturing Excellence of Bio-Synth

Bio-Synth operates with an unwavering commitment to quality. Our manufacturing processes integrate

  • ☐ WHO-GMP (Good Manufacturing Practices) compliance
  • ☐ ISO 9000:2015 certification
  • ☐ Adherence to ICH guidelines and pharmacopeia standards

Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence.

Applications of Carglumic Acid API

Carglumic acid is used together with diet and other medicines to treat and prevent hyperammonemia (too much ammonia in the blood) caused by the lack of a liver enzyme called N-acetylglutamate synthase (NAGS). It is also used together with diet and other medicines to prevent hyperammonemia caused by certain genetic disorders called propionic acidemia (PA) or methylmalonic acidemia (MMA).

Therapeutic Uses and Indications of Carglumic Acid

Used for the treatment of acute and chronic hyperammonaemia in patients with N-acetylglutamate synthase (NAGS) deficiency. This enzyme is an important component of the urea cycle to prevent the buildup of neurotoxic ammonium in the blood.

How Carglumic Acid API Works (Mechanism of Action)

Carglumic acid API is a synthetic structural analogue of N-acetylglutamate (NAG), which is an essential allosteric activator of the liver enzyme carbamoyl phosphate synthetase 1 (CPS1). CPS1 is found in the mitochondria and is the first enzyme of the urea cycle, which converts ammonia into urea. Carglumic acid API acts as a replacement for NAG in NAGS deficiency patients by activating CPS1 but it does not help to regulate the urea cycle.

Why Choose Bio-Synth for Carglumic Acid API

Bio-Synth adheres to stringent quality protocols to ensure that each batch of Carglumic acid API meets comprehensive global quality standards. Our robust quality control practices confirm the purity, potency, and safety of our products, ensuring reliable therapeutic results. We manufacture Carglumic acid API in our 60kL WHO-GMP, ISO certified facility with a capacity of 1 ton/month.

Bio Synth: Carglumic Acid API Suppliers in India

Bio-synth is one of the leading API manufacturers in India that has included Carglumic acid API in its product portfolio. Bio-synth manufactures all intermediates of Carglumic acid API in-house, thereby offering the best quality, price and lead time.

Carglumic Acid API Price in India

Bio Synth is a reputable supplier of pharmaceutical APIs and intermediates, including Carglumic acid API, used to treat hyperammonemia. Bio-Synth offers Carglumic acid API at highly competitive prices tailored to your specific requirements. We ensure the best value while maintaining the highest quality standards. For detailed pricing and further inquiries, please reach out to us directly, and our team will be happy to assist you.

Frequently Asked Questions

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    Carglumic acid API is an orphan drug used to treat and prevent hyperammonemia (too much ammonia in the blood).

    Bio-Synth offers premium-quality Carglumic acid API at competitive prices, tailored to meet your specific requirements. By handling all production stages internally, we maintain strict control over quality while optimizing pricing. For accurate pricing and to discuss your specific needs, we encourage you to reach out with your inquiry. Our team is dedicated to providing timely responses and ensuring your complete satisfaction.

    Bio-synth is one of the top manufacturers of APIs in India. We also manufacture Carglumic acid API, offering top quality, competitive prices, and short lead time.

    Carglumic acid API is used to treat and prevent hyperammonemia (too much ammonia in the blood) caused by the lack of a liver enzyme called N-acetylglutamate synthase (NAGS). It is also used together with diet and other medicines to prevent hyperammonemia caused by certain genetic disorders called propionic acidemia (PA) or methylmalonic acidemia (MMA).

    The chemical composition of Carglumic acid API is C6H10N2O5, which stands for (2S)-2-(carbamoylamino)pentanedioic acid

    Yes, Carglumic acid API is available for purchase in India. Bio-synth is one of the leading manufacturers and suppliers of API products. Please reach out via the enquiry form with your requirement, and we will be happy to assist you.

    Bio-Synth has almost 8 decades of experience manufacturing high-quality APIs, with Carglumic acid API as one of the key products in its product portfolio, making Bio-Synth one of the trusted manufacturers in India.

    Bio-Synth offers high-quality Carglumic acid API that meets global standards like WHO-GMP and ISO 9000:2015 certification. Our rigorous quality control ensures a consistent and reliable Carglumic acid API supply, making us a top choice for Carglumic acid API suppliers in India.

    Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence.

    To place an order for Carglumic acid API, contact Bio-Synth through our customer service team or by filling out the contact form on our website. We provide comprehensive support to guide you through the order process and ensure timely delivery to meet your specific needs.