Piroxicam

CAS number： 36322-90-4

Molecular formula： C15H13N3O4S

molecular weight： 331.34

Chemical structure：

Producers shown on SFDA

(Record date:01/09/2021）

Producer	Documents	GMP Valid till(based on SFDA)
Nantong Jinghua Pharmaceutical Co., Ltd.	GMP	Valid till May 2023
Kaifeng Pharmaceutical (Group) Co., Ltd.	GMP	Valid till November 2020
Liaoyuan Baikang Pharmaceutical Co., Ltd.	GMP	Valid till November 2023
Shandong Fangming Pharmaceutical Group Co., Ltd.	GMP	Valid till July 2024

Producers shown on EP

(Quoted from EP website；record date:01/09/2021）

Substance	Certificate Holder	Certificate Number	Issue Date	Status	End date	Type
Piroxicam	Pfizer, Inc. US 10017 New York City	R1-CEP 2001-427-Rev 01	22/01/2013	VALID	/	Chemistry
Piroxicam powder or micronised	ESTEVE QUIMICA S.A. ES 08024 Barcelona	R1-CEP 1998-080-Rev 02	19/06/2009	WITHDRAWN BY HOLDER	08/02/2010	Chemistry
Piroxicam	RAMDEV CHEMICAL PVT. LTD. IN 401 506 Boisar	R0-CEP 2016-067-Rev 00	05/05/2017	VALID	/	Chemistry
Piroxicam	OLON S.P.A. IT 20053 Rodano	R1-CEP 2013-111-Rev 00	31/01/2020	VALID	/	Chemistry
Piroxicam	Unichem Laboratories Limited IN 400 102 Mumbai	R1-CEP 2014-289-Rev 00	25/02/2021	VALID	/	Chemistry
Piroxicam	ARCH PHARMALABS LIMITED IN 400 072 Mumbai	R1-CEP 2000-034-Rev 08	05/11/2019	VALID	/	Chemistry

Producer:Nantong Jinghua Pharmaceutical Co., Ltd.by Share Ltd, the company currently has 248 specifications of drug approval number, the total assets of the company amounted to 250 million yuan, covers an area of 140000 square meters.

The company's API has obtained 9 International certifications, among which fluorouracil has passed the FDA certification of the United States, and four products such as phenobarbital and butazone have obtained the cos certification of Europe. Among the bulk drugs, fluorouracil obtained the European cos Certificate in 2000, butazone obtained the European cos Certificate in October 2006, and phenobarbital and promethasone have also applied for cos. The annual production capacity of the company is: 1000 tons of APIs and intermediates, 2000 tons of traditional Chinese medicine extraction, 1000 tons of granules, 1.5 billion tablets, 120 million injections and 80 million capsules. The company organizes production in strict accordance with GMP requirements, and the drug quality is in strict accordance with the standards of Chinese Pharmacopoeia, European Pharmacopoeia, British Pharmacopoeia and American Pharmacopoeia.

Staff size:About 2000 persons

Registered capital:RMB 835 million 700 thousand

Producer:Kaifeng Pharmaceutical (Group) Co., Ltd. (hereinafter referred to as "Kaifeng Pharmaceutical Group") was founded in May 1949. Its predecessor is Kaifeng Pharmaceutical Factory in Henan Province, a national comprehensive large class II pharmaceutical enterprise.

The company covers an area of 400000 square meters, a construction area of 170000 square meters, and more than 3000 large and medium-sized advanced production equipment. The production equipment of the enterprise is advanced and perfect, and has fully passed GMP certification and relevant acceptance. Kaiyao group is a high-tech enterprise in Henan Province, with perfect quality assurance system and quality detection and control instruments, and reliable product quality. All kinds of products produced have been spot checked by national, provincial and municipal quality supervision departments, and the qualified rate has been 100% for 23 consecutive years. The product quality meets the standards of Chinese Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia and American Pharmacopoeia. It is the first self-supporting import and export enterprise in the pharmaceutical system of Henan Province approved by the Ministry of foreign economic relations and trade.

Staff size:900-999 persons

Registered capital:RMB 204 million 568 thousand and 562

Producer:Liaoyuan Baikang Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Chongqing Sansheng Industrial Co., Ltd. Its predecessor, Liaoyuan No. 1 pharmaceutical factory, was founded in 1958.

After more than 50 years of accumulation and development, the company now has 104 drug production approval numbers, including 20 APIs and 84 preparations. The leading varieties of API are acetaminophen, chlorpipetin hydrochloride, nefopam hydrochloride, procaine hydrochloride, diphenhydramine hydrochloride, famotidine, dioxpromazine hydrochloride and levofloxacin mesylate. The annual output of preparations is more than 2 billion tablets, mainly including chlorpipetin hydrochloride tablets and compound paracetamol diphenhydramine tablets. The company has import and export rights, and its products are mainly exported to India, Hong Kong, Macao, Taiwan and other countries and regions. The company has passed GMP certification and COS certification, and is applying for FDA certification to obtain a pass for products to enter the European and American markets.

Staff size:About 400 persons

Registered capital:RMB 50 million

Producer:Shandong Fangming Pharmaceutical Group Co., Ltd. is a comprehensive pharmaceutical production enterprise integrating science, industry and trade. It is a secondary unit of Hongye group, one of China's top 500 enterprises. At present, the company mainly produces 5 dosage forms such as small volume injections, tablets, hard capsules, ointments and APIs. There are 128 national drug approval drug document numbers, covering 12 treatment fields, of which 25 varieties are shortlisted in the national catalogue of essential drugs. There are four factories and six subsidiaries, mainly including western medicine preparation, biopharmaceutical and fine chemical industry. The total area is more than 2000 mu.

Staff size:700-799 persons

Registered capital:RMB 210 million

For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978

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