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glycopyrrolate

Solution for injection 0.6mg/3mL, 1mg/5mL

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
United States
GMP approvals
FDA
Manufacturer #17737
This pharmaceutical company specializes in manufacturing sterile medications, with a particular focus on generic respiratory products and 503B outsourcing services. They leverage state-of-the-art facilities to produce over one billion doses daily, emphasizing efficiency, purity, and efficacy. Key therapy areas include respiratory ailments like asthma, emphysema, and COPD. Principal dosage forms likely include inhalers and suspensions. The company holds GMP certifications and boasts a 27+ year track record of delivering high-quality products to hospitals and medical facilities across North America.

Manufacturer usually replies in 5 days

glycopyrrolate

Injection 0.2 mg/ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Canada
GMP approvals
Canada
Manufacturer #37417
A pharmaceutical manufacturer focused on the development, production and distribution of high-quality therapeutic pharmaceutical products, with particular emphasis on sterile injectable medicines alongside other specialty formulations. The company supports partnerships for contract development and manufacturing, aiming to ensure consistent manufacturing practices and reliable supply of its pharmaceutical products to healthcare providers and markets.

Manufacturer usually replies in 2 days

glycopyrrolate

Oral solution 1 mg/5 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Comments
Status: SSPL has successfully developed & established following formulations of glycopyrrolate against RLD Cuvposa. We are in process taking validation batches at our EU-GMP site and soon will be ready with an e-CTD dossier for out-licensing.
Manufacturer #7738
A pharmaceutical manufacturer specialised in both active pharmaceutical ingredients (APIs) and finished dosage pharmaceutical products, with capabilities spanning complex technologies (such as polysaccharides) and advanced intermediate manufacturing. The company’s facilities are certified by major regulatory authorities including US FDA inspection, EU-GMP certification, WHO-GMP certification, plus approvals from COFEPRIS (Mexico) and the Korean MFDS, supporting global supply to multiple regions worldwide.

Manufacturer usually replies in 6 days

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