Biocon Net Profit up 136% to Rs 217 Crore
Bengaluru: BIOCON announced a 136% growth in net profit at Rs 217 crore for the quarter ended December 2018. Revenue surged by 43% to Rs 1,566 crore, from Rs 1,057.90 crore in December 2017. The good performance was led by a higher contribution from the biologics segment, which had the highest EBIT (Earnings before Interest and Tax) margin of 30 per cent this quarter. Revenue from the biologics segment, comprising biosimilars and novel biologics, more than doubled to Rs 449 crore, a growth of 136 per cent year on year during this quarter. The small molecules business saw 27% revenue growth at Rs 469 crore.


Lupin Launches Generic Silodosin Capsules 4mg and 8mg
Lupin has launched Silodosin Capsules 4mg and 8mg, for which it has already received an approval from the United States Food and Drug Administration (US FDA) earlier, the company said in a press note to the exchanges. The drug is the generic equivalent of AIIergan's Rapaflo. "An alpha-l adrenergic receptor antagonist, it is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)," the company added. According to IQVIA MAT’s report published on September 2018 Rapaflo had sales of $198.5mn annually in the US. Lupin Ltd's share price ended at Rs. 888.05, down by Rs. 10.2 or 1.14% from its previous closing of Rs. 898.25 on the BSE. The scrip opened at Rs. 902 and touched a high and low of Rs. 905.90 and Rs. 880, respectively. A total, of 14,98,794 (NSE+BSE) shares have been traded on the counter. The current market cap of the company is Rs. 40,624.81cr.


Sun Pharma gets US FDA approval for generic Ganirelix Acetate injection
New Delhi: Drug major Sun Pharmaceutical Industries said it has received final approval from US FDA for its abbreviated new drug application (ANDA) for generic version of Ganirelix Acetate injection. The generic version is therapeutic equivalent to Organon's Ganirelix Acetate injection, 250 mcg/0.5 ml. Sun Pharma, including its subsidiaries and/or associate companies), announced that Sun Pharma has received final approval from USFDA for its abbreviated new Drug application (ANDA) for generic version of Ganirelix Acetate injection, 250 mcg/0.5 ml, the company said in a regulatory filing. As per IQVIA, Ganirelix Acetate injection, 250 mcg/0.5 ml had annual sales of approximately $67 million in the US for the 12 months ended September 2018, the company said. The commercialisation of this product in the US market is expected in Q4FY19, it added. Shares of the company were trading at Rs 453.85, 7.81 per cent lower than its previous closing price.


Dr. Reddy's Launches Heartburn Drug in US Market
Dr. Reddy's Laboratories said it has launched Omeprazole delayed-release tablets, used to treat frequent heartburn, in the US market. "Dr Reddy's Laboratories has launched Omeprazole delayed-release tablets in the strength of 20 mg, an over-the-counter (OTC) store-brand equivalent of Prilosec tablets, in the US," the company said in a BSE filing. Milan Kalawadia, Dr Reddy's Laboratories Vice President and Head, US OTC and Speciality Rx businesses said, this launch illustrates the company's continued commitment to the OTC business as well as the depth and breadth of its OTC portfolio. Quoting IRI data, Dr Reddy's Laboratories said the combined market of Prilosec OTC and private label omeprazole OTC products had US retail sales of around USD 492 million for the most recent twelve months ending in October 2018. Shares of Dr Reddy's were trading 0.20 per cent higher at Rs 2,695 apiece on the BSE.


Liva Pharmaceuticals Receives Approval from the USFDA for its sANDA, Ranitidine Injection
Liva Pharmaceuticals Limited, a wholly-owned subsidiary company of Cadila Healthcare Limited has received the approval from the USFDA for its supplemental abbreviated new drug application (sANDA), Ranitidine Injection USP, 25 mg/mL, 2 mL Single dose vials and 6 mL Multi-dose vials. It will be manufactured at Liva Pharma’s manufacturing facility at Vadodara and is the first product to be approved from this site for marketing in the US. Ranitidine belongs to the class of medications called H2-antagonists and is used to treat stomach and duodenal (intestinal) ulcers, and prevent them from recurring. It is also used to treat gastroesophageal reflux disease (GERD) and Zollinger-Ellison Syndrome. The injectable form of ranitidine is given for short-term treatment of these conditions when a patient is unable to take this medication orally. The group now has 237 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY 2003-04.


Wockhardt Receives US FDA Approval for Leukaemia Drug
Mumbai: Pharmaceutical and biotechnology major Wockhardt has received approval from the United States Food and Drug Administration (FDA) for an ANDA for 100mg and 400mg tablets of imatinib mesylate, which is used to treat many kinds of cancers and tumours. Wockhardt’s imatinib mesylate tablets are a generic version of Gleevec marketed in USA and other countries by Novartis. Imatinib stops the cancer cells from growing and is indicated for treating cancers like lLeukaemia and some gastro-intestinal tumours. According to IMS MAT1118, the product has sales of US$ 707 million in the US. “Wockhardt is building a portfolio of oncology products in the US and has several pending ANDA’s for oncology products” said Dr. Habil Khorakiwala, Wockhardt founder chairman and group CEO. “Further, oncology and other specialty products have always been a priority area for our US business and this product will further boost this focus” he said. Wockhardt will be launching this product in the United States, in a short period of time. With its nationwide distribution network and its excellent relationship with all major trade, retail and institutional customers, Wockhardt is already a significant player in the US pharmaceutical market. The product is being manufactured at a contract manufacturing facility based near Hyderabad, India.


Pfizer to Stop Manufacturing Operations in Chennai, Aurangabad Units
Chennai: US pharma major Pfizer Inc has decided to shut down its manufacturing units in Irungattukottai, Chennai and Aurangabad, Maharashtra, which came to it through an acquisition of injectables manufacturer Hospira in 2015. Over 1,700 employees working in these two factories are expected to be impacted by the decision. While the company is shutting down the two facilities, plans are afoot to expand the Vizag manufacturing facility, which also came as part of the acquisition. Pfizer said that it conducted a thorough evaluation of the Irungattukottai and Aurangabad sites and concluded that due to a significant fall in product demand, manufacturing at these sites is not viable. “As a result, Pfizer is announcing that both the Aurangabad and Irungattukottai sites will immediately cease manufacturing with the intention to exit both sites as soon as possible in 2019. The exact timing of the exit of the sites is to be determined,” said a Pfizer spokesperson. The Irungattukottai facility currently employs around 1,000 people and Aurangabad site employs around 700. “Our focus is on our colleagues impacted by this decision and we are committed to keeping them informed of the site exit process,” added the company. The Irungattukottai facility was producing beta-lactam antibiotics while the Aurangabad facility was manufacturing penicillin and penem API during the period. It was coming up with a green field expansion plant in Vizag for speciality injectables then. The Chennai facility has received several observations from the US Food and Drug Administration (US FDA) in the past, the latest being in July 2018. This was because it was not following quality control norms and lacks data related to laboratory records. The facility had earlier received observations from the US FDA as part of inspections in 2013 and 2015, according to reports. The Irungattukottai and Aurangabad sites are purely export-oriented and do not supply products for Pfizer’s India commercial operations. The decision to close down these facilities will not affect its other Indian manufacturing sites in Goa, Vishakapatnam (Vizag) and the joint venture site, Zydus Hospira Oncology Pvt Ltd (ZHOPL), a collaboration with Cadila Healthcare formed to manufacture injectable cytotoxic drugs in Ahmedabad. The company announced an expansion to its operations at the Vizag site to bring it up as a global terminally sterilised manufacturing centre of excellence. It will cater to the export markets, such as United States and eventually, to Canada. India will continue to be an important manufacturing location for Pfizer worldwide, said the company.


Cipla Receives Final Approval for Generic Version of Eli Lilly & Co.’s Adcirca® (Tadalafil Tablets 20mg)
Mumbai: Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Tadalafil Tablets 20mg from the United States Food and Drug Administration (US FDA). Cipla’s Tadalafil Tablets 20mg is AB-rated generic therapeutic equivalent version of Eli Lilly & Co.’s Adcirca ®. It is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. According to IQVIA (IMS Health), Adcirca® and its generic equivalents had US sales of approximately $490M for the 12-month period ending November 2018. The product is available for shipping immediately.


AstraZeneca Pharma Inks Pact with Abbott
New Delhi: AstraZeneca Pharma India has entered into a distribution agreement with Abbott Healthcare for the distribution of diabetes medicine Dapagliflozin in India. Dapagliflozin, an innovative Type 2 diabetes medicine, is AstraZeneca Pharma’s leading diabetes medicine. “Under the agreement, Abbott will promote and distribute Dapagliflozin under the brand name GLEDEPA. Abbott will also gain the rights to promote and distribute the combination of Dapagliflozin with Metformin under the brand name GLEDEPA MET,” AstraZeneca Pharma said in a regulatory filing today. AstraZeneca Pharma, which did not share financial details of the agreement, said it will continue to promote and distribute Dapagliflozin under the brand name Forxiga and a combination of Dapagliflozin with Metformin under the brand name Xigduo. Shares of AstraZeneca Pharma were trading 0.54 per cent higher at Rs 1,341.35 apiece on the BSE.


Roquette Acquires a Majority Stake in Crest Cellulose
La Madeleine, France: Roquette, a global leader in plant-based ingredients for Food, Nutrition and Health markets, announced the completion of the acquisition of a majority stake in Crest Cellulose, from Pravesha Industries, a major Pharma packaging company in India. The creation of this joint-venture will reinforce Roquette’s position as a major supplier to the pharmaceutical industry and a global leader in superior natural-based pharmaceutical excipients. The addition of Crest Cellulose’s know-how and production capabilities to Roquette’s strong expertise and track-record in the pharmaceutical excipients market will create new opportunities for both Roquette’s and Crest Cellulose’s customers and employees as the companies both share a commitment towards innovation, quality and excellence. As a privately-owned company incorporated in 2012 and located in Hyderabad and in Nellore (India), Crest Cellulose takes pride in its robust infrastructure and technical platform. The company manufactures a wide range of superior excipients to address a strong and increasing demand in the pharmaceutical market. This strategic investment allows Roquette to expand its offering of pharmaceutical excipients and nutraceuticals, following the acquisition of Blanver Pharmaceutical’s excipients division division (see announcement here) in 2017. It also underpins Roquette’s commitment to increasing its footprint and proximity to customers in India to serve the large and fast-growing pharmaceutical sector. The size of this market was estimated at US$ 33 billion in 2017 and was growing at over 10% per year at the beginning of 2018. India supplies over half of the global demand for various vaccines, and 25% of all medicines in the world.






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