Importance of API Ensuring quality outcomes

Rusan Pharma’s strength lies in its capability to manufacture niche Active Pharmaceutical Ingredients (API) which include especially controlled substances such as Methadone, Buprenorphine and Fentanyl. Our API manufacturing facility located in Ankleshwar (Gujarat, India) operates with strict cGMP norms to ensure that the highest quality of APIs are manufactured and supplied to our customers. The Ankleshwar API manufacturing unit is approved by the European EDQM and has the following Certificates of Suitabilities (CoS) for its APIs:

Sr. No. API GRADE CAS No. STATUS
1 Buprenorphine HCl Ph.Eur. / IP / USP 53152-21-9 CEP : R0-CEP 2017-228-Rev 00
2 Buprenorphine base Ph.Eur. 52485-79-7 CEP : R0-CEP 2015-387-Rev 00
3 Fentanyl citrate Ph.Eur. / IP / USP 990-73-8 CEP : R0-CEP 2016-023-Rev 00
4 Fentanyl base Ph.Eur. / IP / USP 437-38-7 CEP : R0-CEP 2016-018-Rev 00
5 Naltrexone HCl Ph.Eur. / IP / USP 16676-29-2 CEP : R0-CEP 2016-053-Rev 00
6 Naltrexone base In-House 16590-41-3 DMF in CTD Format Available
7 Naloxone HCl Ph.Eur. / IP / USP 51481-60-8 DMF Submitted for CEP
8 Nalbuphine HCl dihydrate In-House 23277-43-2 Filed in S. Africa & Ukraine
9 Bisoprolol Fumarate Hemihydrate Ph.Eur. / IP / BP / USP 104344-23-2 DMF in CTD Format Available
10 Nalmefene HCl In-House / CHP 58895-64-0 DMF in CTD Format Available
11 Eflornithine HCl Monohydrate In-House 96020-91-6 EMA Approved / Submitted for USFDA (Active)
12 Apomorphine HCl Hemihydrate Ph.Eur. / IP / USP 41372-20-7 DMF Submitted for CEP
13 Methadone HCl Ph.Eur. / IP / USP 1095-90-5 DMF Submitted for CEP
14 Promedol HCl In-House Russian ND 64-39-1 Registered in Russia & Kazakhstan
15 n-Butyl cyanoacrylate In-House 6606-65-1