Sildenafil citrate
CAS number： 171599-83-0
Molecular formula： C28H38N6O11S
molecular weight： 666.70
Chemical structure：
Producers shown on SFDA
(Record date:05/09/2021）
Producer | Documents | GMP Valid till(based on SFDA) |
Qilu Pharmaceutical Co., Ltd. | GMP | Valid till July 2023 |
Sichuan Yuanji Pharmaceutical Co., Ltd. | GMP | Valid till January 2023 |
Guangzhou Baiyunshan Chemical pharmaceutical factory | GMP | Valid till January 2021 |
Hebei Changshan Biochemical Pharmaceutical Co., Ltd. | GMP | Valid till September 2022 |
Changzhou Yabang Pharmaceutical Co., Ltd. | GMP | Valid till June 2024 |
Producers shown on EP
(Quoted from EP website；record date:05/09/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Sildenafil citrate | HETERO DRUGS LIMITED IN 500 018 Hyderabad | R1-CEP 2013-002-Rev 00 | 22/01/2019 | VALID | / | Chemistry |
| Sildenafil citrate | MAPRIMED S.A. AR C1440 CNS Buenos Aires | R1-CEP 2013-100-Rev 00 | 09/04/2020 | VALID | / | Chemistry |
| Sildenafil citrate | AZICO BIOPHORE INDIA PRIVATE LIMITED IN 500 038 Hyderabad | R0-CEP 2016-336-Rev 01 | 26/11/2019 | VALID | / | Chemistry |
| Sildenafil citrate | RAKSHIT PHARMACEUTICALS LIMITED IN 500 038 Hyderabad | R0-CEP 2014-361-Rev 00 | 23/09/2016 | VALID | / | Chemistry |
| Sildenafil citrate | MSN ORGANICS PRIVATE LIMITED IN 508 126 Bibinagar Village | R1-CEP 2013-219-Rev 00 | 16/01/2020 | VALID | / | Chemistry |
| Sildenafil citrate | AMOLI ORGANICS PRIVATE LIMITED IN 400 021 Mumbai | R1-CEP 2014-223-Rev 01 | 04/02/2021 | VALID | / | Chemistry |
| Sildenafil citrate | TORRENT PHARMACEUTICALS LIMITED IN 382 428 Village Bhat | R1-CEP 2013-346-Rev 00 | 04/08/2020 | VALID | / | Chemistry |
| Sildenafil citrate | DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad | R1-CEP 2013-082-Rev 00 | 20/05/2021 | VALID | / | Chemistry |
| Sildenafil citrate | MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad | R1-CEP 2012-317-Rev 00 | 12/07/2019 | VALID | / | Chemistry |
| Sildenafil citrate | MACLEODS PHARMACEUTICALS LIMITED IN 400 059 Mumbai | R1-CEP 2014-050-Rev 00 | 31/08/2020 | VALID | / | Chemistry |
| Sildenafil citrate | PHALANX LABS PRIVATE LIMITED IN 500 034 Hyderabad | R0-CEP 2014-283-Rev 00 | 15/02/2016 | EXPIRED | 15/02/2021 | Chemistry |
| Sildenafil citrate | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R0-CEP 2013-332-Rev 00 | 08/03/2017 | VALID | / | Chemistry |
| Sildenafil citrate | JINAN MINGXIN PHARMACEUTICAL CO., LTD. CN 250 216 Zhangqiu City | R0-CEP 2015-357-Rev 00 | 16/03/2017 | VALID | / | Chemistry |
| Sildenafil citrate | CADILA PHARMACEUTICALS LIMITED IN 393 002 Ankleshwar | R1-CEP 2013-291-Rev 00 | 16/12/2019 | VALID | / | Chemistry |
| Sildenafil citrate Process B | PHARMACEUTICAL WORKS POLPHARMA S.A. PL 83-200 Starogard Gdanski | R1-CEP 2013-073-Rev 02 | 02/07/2021 | VALID | / | Chemistry |
| Sildenafil citrate | SMS PHARMACEUTICALS LIMITED IN 500 034 Hyderabad | R1-CEP 2013-060-Rev 00 | 14/01/2020 | VALID | / | Chemistry |
| Sildenafil citrate Process A | PHARMACEUTICAL WORKS POLPHARMA S.A. PL 83-200 Starogard Gdanski | R1-CEP 2013-072-Rev 01 | 12/05/2020 | VALID | / | Chemistry |
| Sildenafil citrate | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2012-375-Rev 00 | 05/08/2019 | VALID | / | Chemistry |
| Sildenafil citrate | RAKS PHARMA PVT. LTD. IN 531 019 Visakhapatnam | R1-CEP 2014-246-Rev 00 | 18/01/2021 | VALID | / | Chemistry |
Producer:Qilu Pharmaceutical Co., Ltd. is one of the first batch of GMP certified enterprises by the State Food and drug administration. Among them, non sterile APIs (fermentation, chemical synthesis), sterile APIs and various preparations have passed the certification of the US Food and Drug Administration (USFDA), the European Drug Quality Council (EDQM), the UK MHRA, the South African pharmaceutical Regulatory Commission (MCC) and other national drug regulatory agencies.
Qilu pharmaceutical has seven production bases including preparation, chemical synthesis and biotechnology and antibiotic fermentation, covering an area of 1.9 million square meters. The company's automatic production line and other main production equipment and testing instruments are purchased from major professional pharmaceutical equipment manufacturers in the world.
Staff size:7000-7999 persons
Registered capital:RMB 60 million
Producer:Sichuan Yuanji Pharmaceutical Co., Ltd., established in 1998, belongs to the pharmaceutical manufacturing industry. Its business scope includes: production of API (thymus Faxin, thymus pentapeptide, sildenafil citrate and Di'ao Xinxuekang), tablets and granules (including traditional Chinese medicine extraction) (operating within the validity period with the license); Purchase of agricultural and sideline products; Planting of traditional Chinese medicine.
Staff size:200-299 persons
Registered capital:RMB 5.68 million
Producer:Guangzhou Baiyunshan Chemical pharmaceutical factory covers an area of 240000 square meters. It is a wholly-owned subsidiary of Guangzhou Baiyunshan Pharmaceutical Co., Ltd. controlled by Guangzhou Pharmaceutical Group. It is a large chemical pharmaceutical enterprise focusing on the production of cephalosporin APIs. Founded in 1987, it is the first batch of enterprises to obtain national GMP certification.
The factory's characteristic product cefathiamidine is the first semi synthetic cephalosporin first developed and listed by Chinese pharmaceutical enterprises in the world, which is protected by national patents. Cefixime was first listed in China by Baiyun Mountain and was only authorized by fujizawa, the original manufacturer of cefixime in China.
Staff size:300-399 persons
Registered capital:/
Producer:Founded in 2000, Hebei Changshan Biochemical Pharmaceutical Co., Ltd. has a registered capital of 935 million yuan and total assets of 3.5 billion yuan. It has four production bases, nine subsidiaries, two overseas companies and two joint ventures. The company is a biochemical pharmaceutical enterprise integrating R & D, production, sales and import and export trade. In the field of heparin, it is a key high-tech enterprise with a complete heparin industrial chain from crude heparin products to low molecular weight heparin injection products. It is one of the leading enterprises of heparin series drugs in China.
The heparin API workshop of the company has obtained CEP certificate and passed the French GMP certification in 2009. The company's application for exporting heparin sodium to DMF in the United States has passed the on-site audit of FDA.
Staff size:About 1000 persons
Registered capital:RMB 935 million
Producer:Changzhou Yabang Pharmaceutical Co., Ltd., established in October 2002, is located at No. 6, Liangchang East Road, Jintan Economic Development Zone, Changzhou City, Jiangsu Province, with a registered capital of 70 million yuan. Its business scope is the production and sales of chemical APIs. It is a subsidiary controlled by Jiangsu Yabang Pharmaceutical Group Co., Ltd.
The company covers an area of 80000 square meters, a construction area of 14000 square meters and a total investment of more than 100 million. It has 6 fine baking bag production lines, 5 synthesis workshops, 1 hydrogenation workshop, 1 testing center and 1 R & D center that meet the requirements of GMP, a set of sewage treatment devices and environmental protection facilities. The greening area is more than 40%, forming a professional company of 500 t / a API and pharmaceutical intermediates.
Staff size:200-299 persons
Registered capital:RMB 70 million
For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978
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Email: paulzhang@yinuopharmchem.com
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