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 HCI IP / USP / Ph.Eur. 53152-21-9 CEP : RO-CEP 2017-228-Rev 00
2 Buprenorphine Base Ph.Eur. 52485-79-7 CEP : RO-CEP 2015-387-Rev 00
3 Fentanyl Citrate IP / USP / Ph.Eur. 990-73-8 CEP : RO-CEP 2016-023-Rev 00
4 Fentanyl Base IP / USP / Ph.Eur. 437-38-7 CEP : RO-CEP 2016-018-Rev 00
5 Naltrexone HCI IP / USP / Ph.Eur. 16676-29-2 CEP : RO-CEP 2016-053-Rev 00
6 Naltrexone Base In-House 16590-41-3 DMF in CTD Format Available
7 Methylnaltrexone Bromide USP 916055-92-0 DMF in CTD Format Available
8 Naloxone HCI IP / USP / Ph.Eur. 51481-60-8 DMF Submitted for CEP
9 Nalbuphine HCI In-House 23277-43-2 Filed in S. Africa & Ukraine
10 Bisoprolol Fumarate IP / BP / USP / Ph.Eur. 104344-23-2 DMF in CTD Format Available
11 Nalmefene HCI In-House / CHP 58895-64-0 DMF in CTD Format Available
12 Eflornithine HCI In-House 96020-91-6 EMA Approved / Submitted to USFDA (Active)
13 Apomorphine HCI IP / USP / Ph.Eur. 41372-20-7 DMF Submitted for CEP
14 Methadone HCI IP / USP / Ph.Eur. 1095-90-5 CEP: RO-CEP 2017-277-Rev 00
15 Oxymorphone HCl USP 357-07-3 DMF in CTD format
16 Promedol HCI In-House Russian ND 64-39-1 Registered in Russia & Kazakhstan
17 n-Butyl Cyanoacrylate In-House 6606-65-1  
18 Pregabalin USP / Ph.Eur. 148553-50-8  
19 Dinalbuphine Sebacate In-House 311768-81-7  

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