Tag: Pharma

Ajanta Pharma bags approval for Entacapone Tablets

04/09/2017 11:03

Leading pharma major, Ajanta Pharma Limited has said that it has received final approval for Entacapone Tablets from US FDA. It is a bioequivalent generic version of Comtan®1 Tablets. Company will be launching the product shortly in 200mg strength tablets.

“Entacapone Tablets is part of an ever growing portfolio of products that Ajanta has developed for the US market. In total, Ajanta has 35 Abbreviated New Drug Application (ANDA) of which it has final approvals for 20 ANDAs; tentative approvals for 2 ANDA; and 13 ANDAs are under review with US FDA,” the company said in a filing to the Bombay Stock Exchange.

Ajanta Pharma Limited is a specialty pharmaceutical formulation company with global headquarters in Mumbai, India. Over 6,500 employees are engaged in developing, manufacturing and marketing of quality finished dosages across 30+ countries.

Meanwhile, shares of the company were trading at Rs 1202.10 apiece, up 0.10 per cent from the previous close at 11:08 hours on BSE.

Advertisements
Jubilant Life eyes speciality pharma biz acquisition in US

Jubilant Life eyes speciality pharma biz acquisition in US

21/03/2017 13:04

Drug maker Jubilant Life Sciences Ltd on Tuesday said its wholly owned subsidiary, Jubilant Pharma Ltd (JPL), likely to negotiate a potential acquisition of a speciality business in the US.

“The Board of Directors of Jubilant Pharma Ltd (JPL), a material wholly owned subsidiary of the company in Singapore, has approved to negotiate a potential acquisition of a specialty pharma business in the United States using only internal accruals, subject to due diligence, satisfactory agreements, etc. and its final approval,” Jubilant Life Sciences Ltd said in a filing to the Bombay Stock Exchange on March 21, 2017.

The company further said that, the proposed acquisition is a niche, profitable speciality pharma business with a strategic fit and is expected to provide competitive edge for JPL’s existing business, if it materialises.

Meanwhile, shares of the company were trading at Rs 785.85 apiece, up 0.06 per cent, from previous close on BSE at 13:09 hours.

Replied to form 483 of USFDA observations, says Divis Labs

Replied to form 483 of USFDA observations, says Divis Labs

09/01/2017 12:25

Hyderabad-based pharma company Divis Laboratories Ltd on Monday said that it has updated on USFDA inspection of the company’s unit-II at Visakhapatnam.

In a filing to the Bombay Stock Exchange, Divis Laboratories said, “The company has already filed its detailed response to the ‘Form 483’ observations of the USFDA within the time permitted.”

Last month, the US health regulator had made 5 observations after inspection of the company’s manufacturing plant at Visakhapatnam.

Meanwhile, shares of the company were trading at Rs 743.80 apiece, up 0.86 per cent, from previous close on BSE at 12:30 hours.

Glemark Pharma bags approval for Tretinoin Capsules

27/12/2016 09:57

Glenmark Pharmaceuticals Inc.,USA has been granted final approval by the United States Food & Drug Administration(U.S.FDA) for Tretinoin Capsules,10mg,the generic version of Vesanoid Capsules,10mg,of Hoffmann La Roche,Inc.(which is no longer being marketed in United States).

According to IMS Health sales data for the 12 month period ending October 2016,the Vesanoid Capsules,10 mg market achieved annual sales of approximately USD 22.0 million.

Glenmark’s current portfolio consists of 112 products authorized for distribution in the U.S.marktplace and 63 pending approval with the U.S.FDA.

Meanwhile, shares of the company were trading at Rs 893 apiece, up 0.44 per cent from the previous close at 10:00 hours on BSE.

Cipla’s Sept quarter net drops 34.7% at Rs 354.34 cr

Cipla’s Sept quarter net drops 34.7% at Rs 354.34 cr

10/11/2016 11:59

Country’s fifth-largest drugmaker Cipla Ltd has reported a decline of 34.7 per cent in its consolidated net profit after taxes (PAT) at Rs 354.34 crore for the second quarter ended September 30, 2016, mainly on account of increase in expenditure.

“The consolidated net profit of the pharma major stood at Rs 543.02 crore during the same period a year ago,” said Cipla Ltd in a filing to the Bombay Stock Exchange.

However, the consolidated total income of the drug maker grew by 8.4 per cent at Rs 3,778.25 crore during Q2 FY17, as compared to Rs 3,485.88 crore during the same period last year.

Commenting on the performance, Cipla, MD and Global CEO, Umang Vohra said, “The performance reflects improvement in the quality of the base business, endorsing our strategic intent of investing in future through increased R&D efforts.”

On standalone basis, Cipla’s net profit fell to Rs 329.24 crore in July-September 2016, from Rs 532.09 crore in the corresponding period a year ago. Moreover, its total income slide to Rs 2,846.76 crore, from Rs 3,108.53 crore a year ago.

The company launched six new products during this quarter in the US market and continues to invest in building a niche and differentiated product portfolio, Cipla said.

Meanwhile, shares of the company were trading at Rs 562.40 apiece, up 6.49 per cent, from previous close on BSE at 12:03 hours.

Dr Reddys Q2 net plummets 60% at Rs 308.9 cr

25/10/2016 17:32

Country’s secong largest drug maker Dr Reddys Laboratories Ltd on Tuesday reported a significant fall of 60.1 per cent in its consolidated net profit after taxes (PAT) at Rs 308.9 crore for the second quarter ended September 30, 2016.

“The consolidated net profit of the company stood at Rs 774.7 crore during the same period a year ago,” said Dr Reddys Laboratories Ltd in a filing to the Bombay Stock Exchange on October 25, 2016.

Pharma major’s consolidated total income too declined by 10.6 per cent to Rs 3,660.1 crore during Q2 2016-17, from Rs 4,093.1 crore over the previous year quarter.

Commenting on the results, Dr Reddy’s, Co-chairman and CEO, GV Prasad said, “All out businesses have shown sequential improvement over the previous quarter. We have made considerable progress in our remediation efforts and continue to work on addressing the concerns of the regulators.”

He said his company was focusing on launching new generic products and improving productivity.

During the quarter, the Research & Development (R&D) spend at Rs 5.2 billion (14.5 per cent of revenue).

Meanwhile, shares of the company closed at Rs 3200.45 apiece, up 3.59 per cent from previous close on BSE.

Panacea Biotec witnesses shortage of Cilamin 250 capsule

29/09/2016 16:53

Pharma company Panacea Biotec Ltd on Thursday said it is witnessing a shortage of life saving drug Cilamin 250 capsule in the retail market due to non availability of raw material D-Penicillamine in India.

“Panacea Biotec ensures limited availability of life saving drug Cilamin 250 capsule (D- Penicillamine IP 250 mg),” the company said in a filing to the Bombay Stock Exchange on September 29, 2016.

The drug is used for treatment of Wilson’s disease, rheumatoid arthritis and other conditions.

“The temporary shortage is due to sudden disruption of supplies of raw material by qualified supplier beyond the control of the company. Since then company has been working tirelessly with alternate suppliers for supply of this raw material. Due to continuous efforts we have resumed limited production of Cilamin 250 and have released limited quantities in the market from September 26, 2016,” the company said in a statement.

However, it has started the supply of new batches with limited quantities of Cilamin 250 from September 26, 2016 from its manufacturing facility in Baddi, Himachal Pradesh under Good Manufacturing Practices, the company added.

The company further said that, it will continue to work closely with existing and potential new raw material suppliers in China and India for access to the raw material in an accelerated manner.

Meanwhile, shares of the company closed at Rs 110.55 apiece, down 5.47 per cent, from previous close on BSE.

Jubilant Life Sciences’ arm proposes to raise funds

23/09/2016 11:38

Jubilant Life Sciences said that its material wholly-owned subsidiary’s board of directors approved offering of unsecured high yield bonds.

“The board of directors of company’s material wholly-owned subsidiary, Jubilant Pharma (JPL) at a meeting held today, 23 September 2016, approved the proposal to launch a benchmark offering of unsecured high yield bonds (notes) outside India by JPL,” the company said in a filing to the Bombay Stock Exchange.

The notes are proposed to be listed on the Singapore Exchange Securities Trading.

Jubilant Pharma is a company incorporated under the laws of Singapore outside India.

Meanwhile, shares of the company were trading at Rs 643.50 apiece, up 3.73 per cent from the previous close at 11:42 hours on BSE.

Pfizer deal indicates US pharma trend for targeted M&A: Fitch

Pfizer deal indicates US pharma trend for targeted M&A: Fitch

24/08/2016 15:50

Pfizer’s proposed acquisition of Medivation highlights the trend of large innovative US pharmaceutical firms continuing to pursue targeted acquisitions rather than large transformative ones, according to Fitch Ratings.

Fitch Ratings said in a report that consolidation continues as big pharmaceutical firms search for scale and efficiencies. However, as the number of new drugs in the pipeline increases, and manufacturers face manageable patent expiry risks, large acquisitions will become less necessary, it said.

The agency expects larger manufacturers to seek out individual therapeutics and smaller biotech companies through targeted acquisitions and partnerships designed to strengthen innovative drug portfolios.

Pfizer’s deal announced this week is a good example. Medivation sells a prostate-cancer drug with significant growth potential in the oncology space and has two pipeline products. The all-cash deal for approximately USD 14 billion will be marginally positive for Pfizer’s leverage as the company will fund the acquisition with balance sheet cash while acquiring EBITDA from a product that is already on the market and growing.

Pfizer’s acquisition of Anacor in June is another example of a recent targeted acquisition. Anacor’s eczema treatment crisaborole will be an important near-term asset for the company.

Other transactions include Bristol-Myers Squibb’s acquisition of Padlock Therapeutics, which could expand its presence in the treatment of rheumatoid arthritis. In its acquisition of Glycostasis, Inc., Eli Lilly looks to develop a form of insulin that self-releases when a diabetic patient’s blood-sugar level is too high.