Adenosine

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

27 API Suppliers, 20 USDMF, 3 CEP/COS, 1 EU WC, 4 NDC API, 8 Listed Suppliers

PRICE INFORMATION

API Reference Price, API Exports, API Imports

DOSSIERs // Finished Dosage Formulations

56 Dossiers, 33 FDA Orange Book, 5 Europe, 4 Canada, 2 South Africa, 12 Listed Dossiers

DRUG PRODUCT COMPOSITION

INJECTABLE;INJECTION - 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - 60MG/20ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - 90MG/30ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAVENOUS - 60MG/20ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAVENOUS - 90MG/30ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

Suppliers, 31 Roquette, 28 Seppic, 23 Nanjing Well Pharmaceutical, 20 BASF, 19 DKSH, 18 Kerry, 16 Corel Pharma Chem, 16 Gangwal Chemicals, 14 SPI Pharma, 12 Microlex e.U, 11 Actylis, 10 Evonik, 7 Rochem International Inc, 6 Lonza Capsugel, 6 Lubrizol Life Science Health, 4 Nanjing Bold Chemical, 4 ACG Worldwide, 4 Kima Chemical, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Finar, 4 Ideal Cures Pvt Ltd, 4 Gangwal Healthcare, 3 The Dow Chemical Company, 3 Sigachi Industries, 3 Shandong Focus Biotechnology Co., Ltd, 2 Nippon Fine Chemical, 2 Qualicaps, 2 BioSpectra, 2 Aeon Procare, 2 Clariant, 2 Ingredion Pharma Solutions, 2 Hayashibara, 2 Pfanstiehl, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Kewpie Corporation, 1 Pharm-RX Chemical, 1 Zhejiang Huakang Pharmaceutical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Bioplus Life Sciences, 1 Vertellus, 1 Jai Radhe Sales

EXCIPIENTS BY APPLICATIONS

77 Topical, 61 Solubilizers, 48 Coating Systems & Additives, 40 Thickeners and Stabilizers, 33 Fillers, Diluents & Binders, 33 Parenteral, 31 Emulsifying Agents, 26 Film Formers & Plasticizers, 26 Taste Masking, 22 Controlled & Modified Release, 19 Surfactant & Foaming Agents, 17 Direct Compression, 14 Co-Processed Excipients, 12 Lubricants & Glidants, 11 Chewable & Orodispersible Aids, 10 Granulation, 9 Empty Capsules, 9 API Stability Enhancers, 9 Rheology Modifiers, 8 Disintegrants & Superdisintegrants, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Soft Gelatin

GLOBAL SALES INFORMATION

3 Finished Drug Prices

3 Finished Drug Prices

MARKET PLACE

18 APIs, 1 DOSSIERS // FDF

ANALYTICAL SOLUTION(s)

1 EDQM Standards, 1 USP Standards, 1 Other Ref. Standards

DIGITAL CONTENT

2 Data Compilations & Company Tracker #PharmaFlow, 15 News

Blog

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Compliance troubles emerge at Pfizer, Teva, Wockhardt and Xiamen Origin

It has been an unprecedented week where compliance glitches have emerged from almost all parts of the globe. This week, PharmaCompass brings you a compilation of such troubles to give you an idea about the nature of such compliance issues. And, the problems regulators are facing walking the tightrope between drug safety and drug availability. Pfizer halts production in India after joint inspection by four regulatorsPfizer recently halted production at a plant near Chennai in India, after a PIC/S (short for Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) joint inspection with regulators from four international agencies, MHRA (Medicines and Healthcare products Regulatory Agency of the UK), USFDA (United States Food and Drug Administration), TGA (Therapeutic Goods Administration of Australia) and Health Canada, found various quality control problems. A Pfizer spokesperson told The Economic Times: “A holistic plan is being developed to address specific inspection observations and to implement enhancements to site operations.” The plant was acquired by Pfizer through its US $ 17 billion acquisition of Hospira, which had run into a fair share of manufacturing compliance problems with the FDA. Over the last few years, numerous Hospira plants — including those in the United States, Europe, Asia, and Australia — received warning letters and had to subsequently issue product recalls. The same facility in Chennai received an FDA warning letter in 2013. Pfizer’s own operations in Asia ran into problems when US FDA investigator Peter Baker uncovered data integrity malpractices at a finished dosage manufacturing facility in Dalian (China). Teva recalls product exempted from import alert on Hungarian facilityA little over two months ago, Teva’s largest sterile medicines plant in Hungary was placed on FDA’s import alert list. When the alert was announced, all drugs produced at the finished dosage forms facility – barring antibiotics Amikacin and Bleomycin – were placed on the import alert list. With a large chunk of drugs and drug ingredients being manufactured outside the US, the American regulator has had to increase its international oversight and ban products manufactured in plants that do not meet the regulatory standards. However, these bans have led to drug shortages. As a result, the FDA has had to (sometimes) exempt products and allow imports from plants that it believes have a poor record. According to the FDA Import Alert records, since 2013 the FDA has allowed eight plants whose products are otherwise banned from the US to go ahead and import some drugs or ingredients in order to avoid drug shortages. Amikacin manufactured at Teva’s Hungary plant was once such drug.However, the FDA’s exemption to prevent a drug shortage suffered a setback when Teva announced a voluntary recall of seven lots of Amikacin Sulfate Injection due to the potential for the presence of glass particulate matter. This announcement follows a similar announcement by Teva when one lot of Amikacin was recalled in March this year. Wockhardt back on FDA’s import alert listJust when it seemed Wockhardt was getting its compliance act together and putting its problems behind it, its bulk drug facility got placed on the FDA’s Red List. The bulk drug division in Ankleshwar (Gujarat) is the latest to join FDA’s import alert list, with Wockhardt’s Waluj and Chikalthana (Maharashtra) units already on the list. While Wockhardt recently said it had received establishment inspection reports (EIR) for the facilities with observations, it also mentioned that the “receipt of EIR does not materially change the status of import alert for the concerned manufacturing units for the US market.” The bulk drug facility in Ankleshwar had received a EU Written Confirmation from the Indian Central Drug Authority for the following seven products – dextromethorphan hydrobromide, adenosine, tamsulosin, nicardipine, cefuroxime axetil, fexofenadine and ceftriaxone sodium. FDA’s warning letter to China’s Xiamen reveals horrific details of GMP deficiencies Chinese drug maker Xiamen Origin Biotech (known as Attix Xiamen Pharmaceutical in North America) was placed on the FDA Import Alert list in May 2016. However, it was only recently that its warning letter was put up on the FDA website, bringing to light the magnitude of GMP deficiencies. According to the warning letter, the company “repeatedly falsified and omitted information on the certificate of analysis (CoA)” issued to customers and went to the extent of fabricating the name of an employee, which was used as a false signing authority on the CoA sent to customers.The company also included an ‘expiration date’ which exceeded the manufacturer’s labeled expiration date without any basis for the extension. In addition, the company made deceptive statements to the investigator, who also found dirty warehousing spaces and a rodent in the room adjacent to the warehouse.The FDA’s action in China follows an import alert which was placed on the North American operation of the company – Attix Pharmaceuticals – in Canada in February 2015. The warning letter issued to Attix Canada showed the company was packaging highly potent beta-lactam products “in a facility that is not dedicated to manufacturing beta-lactam drugs”. The practices created “an unacceptable risk of beta-lactam cross-contamination in other beta-lactams and in non-beta-lactam APIs”.An outcome of the North American inspection was a series of API recalls in both the United States and Canada. Japanese camphor producer refuses inspection; lands up on FDA’s Red ListWhile Wockhardt got placed on FDA’s import alert list as an outcome of an inspection, Nippon Fine Chemical in Japan appeared on the dreaded Red List for refusing to be inspected.Nippon Fine Chemical produces pharmaceutical grade Camphor, an active ingredient (along with menthol) in vapor-steam products, such as Vicks VapoRub. Inno Pharma’s Vitamin D drops with 75 times higher content recalled in DenmarkIn Denmark, Vitamin D drops made by Inno Pharma were recalled recently as the content was “75 times too high”. The product is marketed to infants and pregnant women in Denmark, and sold under the brand ‘Vitamin D3-draber’.The hazardous nature of the drops made the Danish Health Authority (Sundhedsstyrelsen) advise anyone who had taken ‘Vitamin D3-draber’ from Inno Pharma for a week or longer to see their doctor for a blood test to assess the risk posed to them of Vitamin D toxicity. Also known as hypervitaminosis D, this is a rare but potentially serious condition that occurs when you have excessive amounts of vitamin D in your body. The main consequence of vitamin D toxicity is a buildup of calcium in your blood (hypercalcemia), which can cause poor appetite, nausea, vomiting, weakness, frequent urination and kidney problems.

Impressions: 7174

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#Phispers by PHARMACOMPASS

11 Aug 2016

Zhejiang Hisun’s FDA import alert; a new chapter in the fight against data integrity

A few months ago, PharmaCompass covered the Health Canada request to quarantine drugs linked to leading Chinese drug maker, Zhejiang Hisun Pharma (Hisun) due to data integrity concerns.The “interim precautionary measure” was taken “in light of recent findings from a trusted regulatory partner that raised concerns about the reliability of the laboratory data generated at this site”.Last week, the trusted regulatory partner – i.e. the United States Food and Drug Administration (FDA) – announced it had placed Zhejiang Hisun Pharma on its import alert list. Regulators unite against data integrity violations International regulatory agencies are collaborating with each other at an unprecedented pace. Health Canada’s decision to quarantine drugs from Hisun almost three months before FDA’s official action indicates an extremely low level of tolerance for companies that fail to maintain data integrity. Health Canada has also taken similar action against companies who have recently failed European inspections (e.g. India’s Polydrug Laboratories and China’s Jinan Jinda Pharmaceutical Chemistry). Polydrug Laboratories was also included in the most recent FDA Import Alert list indicating a growing impatience in international regulatory agencies against non-compliant firms. Last week, Brazilian Health Surveillance Agency (ANVISA) announced suspending import of all APIs from India’s Parabolic Drugs. ANVISA’s resolution was driven by Parabolic’s failure of a European Good Manufacturing Practices (GMP) inspection in July this year Hisun’s importance in the pharmaceutical supply chainThe FDA decision to ban almost all products coming from the Hisun facilities into the United States is going to create significant disruption in the pharmaceutical supply chain, given the colossal scale of Hisun Pharma’s operations.Zhejiang Hisun Pharma qualifies as one of the most prominent active pharmaceutical ingredients (API) manufacturers in the business, with more than 93 Drug Master Files submitted with the FDA, four approved finished products listed in the FDA Orange Book and 35 Certificates of Suitability issued by the European Directorate of Quality Medicine,.Hisun’s core operations in Taizhou city cover a very large area and are divided into three parts (the Yantou campus; Waisha Campus; and East Factory) which are separated by public roads. The Taizhou site employs approximately 4,000 people and focuses on fermentation-based anti-infectives, cardiovascular products (e.g. statins) along with synthetic anti-cancer products. Hisun’s branded generic player ambitions Two years ago, Hisun’s ambitions to transform itself from an API maker to a branded generic company were announced through the launch of Hisun-Pfizer Pharmaceutical Co., a joint venture with Pfizer where Hisun has a controlling stake of 51 percent while Pfizer has the balance 49 percent.With a vision to become “a widely respected international pharmaceutical company,” Hisun exports more than “80 percent of its API products” to more than 30 nations and regions. Hisun will not disappear post the import banHowever, Hisun’s importance in the supply chain is demonstrated by the number of exemptions which the FDA had to make in order to ensure that there are no drug shortages created as an outcome of the import alert. Fourteen products have been excluded from the import alert. Bleomycin, Capreomycin, Daunorubicin Citrate Liposomal, Doxorubicin Hydrochloride, Mitomycin, Tazobactam, Granisetron, Cladribine, Cyclophosphamide finished form and API, Cytarabine, Floxuridine, Fludarabine, Ivermectin and Adenosine will still be allowed entry into the United States from the Hisun plant. Our viewLast month we analyzed if “speedy action by European agencies suggest revival of API production in the West” and suggested that the era where companies were securing their supply of APIs by looking for low-cost players in Asia appears to be waning away.With a major Chinese player like Hisun now running into severe compliance problems and the number of alternatives available being quite limited, we foresee a significant shift in the pharmaceutical supply chain.

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#Phispers by PHARMACOMPASS

17 Sep 2015

Find PharmaFlow Article for Adenosine

Adenosine

Adenosine

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

27 API Suppliers

20 USDMF

3 CEP/COS

1 EU WC

4 NDC API

8 Listed Suppliers

PRICE INFORMATION

API Reference Price

API Exports

API Imports

DOSSIERs // Finished Dosage Formulations

56 Dossiers

33 FDA Orange Book

5 Europe

4 Canada

2 South Africa

12 Listed Dossiers

DRUG PRODUCT COMPOSITION

INJECTABLE;INJECTION - 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INTRAVENOUS - 60MG/20ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INTRAVENOUS - 90MG/30ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

Suppliers

31 Roquette

28 Seppic

23 Nanjing Well Pharmaceutical

20 BASF

19 DKSH

18 Kerry

16 Corel Pharma Chem

16 Gangwal Chemicals

14 SPI Pharma

12 Microlex e.U

11 Actylis

10 Evonik

7 Rochem International Inc

6 Lonza Capsugel

6 Lubrizol Life Science Health

4 Nanjing Bold Chemical

4 ACG Worldwide

4 Kima Chemical

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 Finar

4 Ideal Cures Pvt Ltd

4 Gangwal Healthcare

3 The Dow Chemical Company

3 Sigachi Industries

3 Shandong Focus Biotechnology Co., Ltd

2 Nippon Fine Chemical

2 Qualicaps

2 BioSpectra

2 Aeon Procare

2 Clariant

2 Ingredion Pharma Solutions

2 Hayashibara

2 Pfanstiehl

2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

2 Kewpie Corporation

1 Pharm-RX Chemical

1 Zhejiang Huakang Pharmaceutical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

1 Bioplus Life Sciences

1 Vertellus

1 Jai Radhe Sales

EXCIPIENTS BY APPLICATIONS

77 Topical

61 Solubilizers

48 Coating Systems & Additives

40 Thickeners and Stabilizers

33 Fillers, Diluents & Binders

33 Parenteral

31 Emulsifying Agents

26 Film Formers & Plasticizers

INJECTABLE;INJECTION - 3MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - 60MG/20ML (3MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - 90MG/30ML (3MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons