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Top drugs and pharmaceutical companies of 2019 by revenues

Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues. Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively. Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention. GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion). US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic. Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)

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29 Apr 2020

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COVID-19: India restricts drug exports amid rising prices of essential bulk drugs; FDA announces first drug shortage

Now that it has been established that the novel coronavirus is going to globally impact the drug supply chain, it becomes imperative to analyze the extent of the impact. Since the outbreak of the novel coronavirus — COVID-19 — in December, PharmaCompass has been constantly reaching out to manufacturers around the world to assess the current state of the drug supply chain. This week, we share our preliminary analysis based on the feedback we have received from drug manufacturers around the world. Drug shortages are for real Last week, the US Food and Drug Administration (FDA) announced the first human drug shortage as a result of the coronavirus outbreak. In addition, the FDA announced it was tracking 20 drugs that could face shortages. Some generic drugmakers are predicting shortages as early as in June or July, due to the novel coronavirus. The FDA did not disclose the name of the drug in shortage or the 20 drugs it is tracking, as this is considered ‘confidential commercial information’. In India, a committee constituted by the country’s Department of Pharmaceuticals started monitoring the availability of 58 active pharmaceutical ingredients (APIs) to take preventive measures against illegal hoarding and black-marketing in the country. According to a report published in The Economic Times, after reviewing the list of drugs, 34 were found to have no alternatives which include critical and essential drugs like potassium clavulanate, ceftriaxone sodium sterile, piperacillin tazobactam, meropenem, vancomycin, gentamycin and ciprofloxacin. This was immediately followed by the Indian government restricting the exports of 13 APIs along with some of their finished formulations. The list includes paracetamol, tinidazole, metronidazole, acyclovir, vitamin B1, vitamin B6, vitamin B12, progesterone, chloramphenicol and neomycin. For most of the products on this list, India is a net importer, as there is little domestic manufacturing of these APIs. COVID-19 is also likely to impact bottomlines. Leading generic drugmaker Mylan said it expects the coronavirus outbreak to impact its financial results while some of the largest drugmakers — including AstraZeneca, Merck and Pfizer — have said that the coronavirus outbreak could affect their supplies or sales. Paracetamol affected; prices double in less regulated markets The decline in industrial activity in China is certainly taking its toll, as drugs which are on the World Health Organization’s Model list of Essential Medicines are beginning to face significant price increases in the wake of disruption of key starting raw materials for bulk drugs. The export restriction out of India on commonly used analgesic, Paracetamol — sold under the brand names such as Tylenol (in the US), Panadol (in the UK), Dafalgan (France) and Crocin (India) — is not surprising as the API has witnessed almost doubling of prices in less regulated markets because exports of its key building block para-amino phenol (PAP) have dramatically reduced from China. While there are only a few manufacturers who produce paracetamol without being dependent on Chinese PAP, a few major manufacturers in India depend almost completely on Chinese PAP for their paracetamol production and usually only keep three to four months of inventory. By the end of February, their inventory stockpiles had halved and in the event of a continued supply disruption, their entire inventory pipeline is likely to dry out. In addition, Chinese paracetamol manufacturers, who export a significant amount of their bulk ingredient production globally, including to India, are also currently unable to export. This is beginning to create the potential of panic among sourcing executives across the world. Several antibiotics also in danger of acute shortages While paracetamol was listed on the API watch list circulated by India’s Department of Pharmaceuticals, our survey has revealed that other products on the list like ciprofloxacin, amoxicillin and azithromycin are also facing severe raw material shortages. As a result, the prices of these bulk drugs have also increased sharply. In a statement to The Economic Times, leading Indian generic manufacturer Mankind Pharma’s chairman and managing director said amoxicillin is the most commonly used API to manufacture antibiotics and the company has invested Rs 1 billion (US$ 14 million) in placing irregular orders with vendors to try and address the potential shortage that is expected. He went on to say that if the situation continues until April, there will be an acute shortage. In a statement to the US House of Representatives last October, Janet Woodcock, the FDA’s Director of Center of Drug Evaluation and Research, said the FDA has determined that there are three WHO Essential Medicines whose API manufacturers are based only in China. The three medicines are: capreomycin, streptomycin (both indicated to treat Mycobacterium tuberculosis) and sulfadiazine (used to treat chancroid and trachoma). Streptomycin is also on the watch list published by India’s Department of Pharmaceuticals along with commonly used anti-hypertensives like losartan, valsartan, telmisartan and olmesartan and diabetes treatment metformin. Intermediates becoming a problem for generic drugmakers PharmaCompass’ discussions have also revealed that in many cases while API manufacturing factories in China have returned to work, there are disruptions in the availability of raw materials and/or logistics at sea ports and airports which have led to unavailability of supplies. While the FDA has a list of the number of API facilities in China which are in a position to supply to the United States, Woodcock said in her statement that the FDA “cannot determine with any precision the volume of API that China is actually producing, or the volume of APIs manufactured in China that is entering the US market.” This visibility reduces drastically when one has to assess the dependence of each API manufacturer around the world on China for intermediates. Our discussions have revealed that it is these intermediates which are becoming a problem for most API manufacturers, even those based in India. It was worth highlighting that a manufacturing process change at an intermediate stage of commonly used blood pressure medicine valsartan resulted in the recall of millions of pills as it was found to contain a cancer causing impurity above acceptable levels. Similarly, in 2008, the adulteration of heparin in China, which killed 81 people and left 785 severely injured, was an outcome of the subcontracting of precursor chemicals of Heparin. Our view The over-dependence on China for key starting materials has been the subject of discussion ever since we launched PharmaCompass. Rosemary Gibson explored this subject in detail in her book China Rx: Exposing the Risks of America’s Dependence on China for Medicine. The restrictions imposed on industrial activity and transportation in China in the first two months of this year has resulted in NASA’s satellite images showing a decline in pollution levels over China. While China works towards getting its industrial and transportation engine up and running to 2019 levels, the outbreak has spread to other countries which will further increase the demand for drugs to fight the virus. This is a time when the pharmaceutical industry needs to act responsibly and make decisions which are in the best interests of patients globally. Sharing information is one such step — it will allow for drug stockpiles and inventories that exist to be re-distributed to areas which need them most. For, in the event of an urgent need, drugs will become available to those who are most in need.

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04 Mar 2020

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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.

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11 Aug 2016

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Lupin’s FDA inspections, how serious are the concerns?

Lupin, India’s third largest pharmaceutical company by sales, was in the news recently as it recalled multiple batches of products manufactured at its facility in Mandideep (Madhya Pradesh, India). The US Food and Drug Administration (FDA) announced the recall just one week after Lupin had announced a successful close-out of the FDA’s inspection concerns at its Mandideep facility. In a statement to the stock exchange, the company had mentioned that the FDA had conducted audits at Lupin’s Mandideep facility from February 8 to 19 this year, and at its Aurangabad facility from January 11 to 15, 2016. It isn’t all sunny in GoaThe statement made no mention of the status of FDA’s inspection at Lupin’s plant in Goa, the largest revenue contributor to Lupin’s US business. In a recent interview, Lupin’s Managing Director, Nilesh Gupta, did highlight that while the inspections at Mandideep and Aurangabad were closed successfully, the company will “not get new approvals from Goa”.The PharmaCompass team reached out to FDAZilla.com to gain access to the Form 483s issued by the FDA to Lupin’s Goa formulations manufacturing facilities, where Lupin had expanded capacities by 50 percent last year. The manufacturing plant in Goa has been inspected twice by the FDA in the last year and a review of both inspections indicates a bumpy road ahead for Lupin. “With Goa and Mandideep, almost entire US business for Lupin (ex-Gavis) has come under regulatory scrutiny,” says a Capitalmind report. ‘Testing into compliance’ instead of finding the root-causeSimply put, in case there is a problem in the quality of a product, Good Manufacturing Practices (GMP) require that the company identifies the root-cause that triggered the problem.“FDA prohibits sampling and testing with the goal of achieving a specific result or to overcome an unacceptable result (e.g., testing different samples until the desired passing result is obtained). This practice, also referred to as testing into compliance, is not consistent with cGMP (current GMP),” states FDA’s recently published guidance “Data Integrity and Compliance with cGMP” In the July 2015 inspection at Goa, FDA investigators found seven instances where batches that generated ‘Out of Specification’ results and failed in-process specifications, had the finished product released by the quality control unit (QCU) and distributed without invalidating the out of specification results. The investigators also found over 40 complaints, related to different batches of a suspension product which finally “the firm stopped manufacturing” but did not conduct an evaluation on in order to assess the need for any market action (for example, a recall). Continuing with GMP malpractices In March 2016, the FDA inspectors were back and once again they uncovered “no scientific basis for invalidating an initial out of specification” result. The “testing into compliance” concern was further magnified as FDA inspectors felt Lupin “failed to design a process suitable for routine commercial manufacturing that can constantly deliver a drug product that meets its quality attributes”. The inspectors have cited multiple instances where “there is no high degree of assurance that the process is reproducible”.In addition, FDA inspectors highlighted concerns over the cleaning procedures adopted at the Goa site. Instead of using a vacuum or dry wipe to remove the previous product, operators sprayed the product with water which resulted “in a large pool of water mixed with powder covering the floor of the production suite during the cleaning operation”. Lack of management or quality assurance review of cleaning records, operators not following appropriate procedures to “prevent objectionable microorganisms in drug products” and cleaning procedures that were found deficient made the inspectors highlight the risk of cross-contamination between products at the facility. Our viewLupin’s recent recall of products from their Mandideep facility mentions “cGMP deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications” as the reason for the recall.The concerns at the Goa facility are along similar lines. And it would not be surprising if Lupin starts recalling products made at the Goa facility. In addition, while there are “no pending applications” for new drugs from Mandideep, Lupin’s new product filings from Goa could be impacted. Nilesh Gupta expects that within the next three months, Lupin should “close everything” it committed to the FDA. However, given PharmaCompass’ experience gained from tracking problems at other major companies in India like Zydus Cadila, Mylan, Dr. Reddy’s, Sun Pharma, Ipca Laboratories and Emcure, we expect Lupin’s journey towards gaining favor with the FDA to be a lot longer.

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16 Jun 2016

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