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2018年1月至3月印度制药公司获得美国FDA批准的51个简化的新药申请(ANDA)

时间:2018-04-12  作者:药网编辑  来源:

2018年1月至3月美国FDA的总共112个批准中,印度制药公司在2018年的第1季度获得了51个美国FDA批准的简化的新药申请(ANDA)批准。 这占在2018年第1季度美国FDA总审批的45%。 去年同期,印度公司在美国FDA批准的171个批准中获得了55个简化的新药申请(ANDA)的批准。 此外,印度公司在2018年1月至3月的第1季度获得了总共23个临时批准中的6个临时批准。整体批准下降至112个,而去年同期则为171个,其中临时批准为23个,临时批准为43个。

2018年第1季度期间,Aurobindo 制药公司在印度公司中获得了简化的新药申请(ANDA)批准的最高数量。它获得了11个简化的新药申请(ANDA)批准,其后分别是Strides Shasun公司 6个,Lupin公司 5个,Cipla公司和Zydus 制药公司4个,Reddy公司,Hetero公司和 太阳制药公司各3个。 Macleods 制药公司和Vivimed 全球公司每家获得2个批准。 Alkem公司,Gland 制药公司,Glenmark 制药公司,印度颗粒公司,Jubilant 生命公司,Laurus公司,Micro公司和Torrent制药公司在2018年的第1季度分别获得了1个简化的新药申请(ANDA)的批准。

截至2017年12月的全年,印度公司在美国FDA的846个批准中获得304个简化的新药申请(ANDA)批准,并从172个批准中获得61个临时批准。 在印度公司中,美国Zydus 制药公司在2017年

获得了66个简化的新药申请(ANDA)的最高批准,其后是Aurobindo公司的51个和Glenmark 公司的18个。 领先的印度公司正在大量投入研发经费以应对国际竞争,并在美国和欧洲等高度管制的市场上提交新产品。 Lupin公司, Dr Reddy公司, Alkem 公司, Biocon公司, 医疗保健公司, 太阳制药公司, Ajanta 制药公司等,都正在应对国际领域的竞争。

截至2017年12月的头9个月期间,Lupin公司的总收入研发支出从1,639千万卢比下降至1,450 千万卢比。Lupin公司在第3季度提交了5个简化的新药申请(ANDA)并获得了美国FDA的6个批准。截至2017年12月31日,其向美国FDA的简化的新药申请(ANDA)申请累计为382件,截至目前该公司已获得231个批准。该公司现在有33个首次申请(FTF)的申请,其中包括16个独家的首次申请(FTF)机会。

截至2017年12月底的9个月期间,Dr Reddy公司的研发支出从1,497 千万卢比降至13.992千万卢比。截至2017年12月底,DRL公司有102个通用名药申请尚待美国FDA的批准(99 个简化的新药申请(ANDA)和3个新药申请)。 Alkem 公司的研发支出在截至2017年12月的前3季度从228.9 千万卢比增加至252.9 千万卢比,增加至总收入的5.1%。

因此,截至2017年12月底共提交了96个简化的新药申请(ANDA)的申请,其中41个为Para IV申请,其中包括首次申请文件。

它获得了总共48个简化的新药申请(ANDA)的批准。所有适用于美国市场的6个生产工厂都有EIR(美国FDA检查报告(建立)),并且没有任何待定的观察结果。

截至2017年12月的前9个月期间,Biocon公司的研发费用从201千万卢比下降18%至165千万卢比。Cadila公司在截至2017年12月的季度期间,在美国市场获得美国FDA批准的24种新产品,并向美国FDA提交了10个简化的新药申请(ANDA)。该季度在美国上市了两种新产品。

Alembic 制药公司的研发支出从前一年的121千万卢比下降到截至2017年12月的第3季度 的98 千万卢比。

它在12月的季度获得了一个简化的新药申请(ANDA)的批准,其累计总数达到了63个简化的新药申请(ANDA)批准。该公司提交了4个简化的新药申请(ANDA),其简化的新药申请(ANDA)申请累计达到108个(收购Orit 公司达119个)。它在美国上市了两种新产品。

因此,印度公司很有可能在高度监管的市场中抓住未来的机会。尽管美国FDA在过去几年中对质量采取行动,但印度制药公司有能力推

出新产品。

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《医药快讯》译自《INTERNET》APRIL,2018

英文原文见下页:

Indian pharma companies secure 51 final ANDA approvals during Jan-March 2018

April 9, 2018

Indian companies have secured 51 final ANDA approvals from

US FDA during the first quarter of January-March 2018, out of

total 112 approvals. This worked out to 45 per cent of total

approvals in the first quarter. During the same period last year,

Indian companies had grabbed 55 final ANDA approvals out of

171 approved by US FDA. Further, Indian companies received

6 tentative approvals from aggregate 23 tentative approvals in

the first quarter of Jan-March 2018. The overall approvals

declined to 112 ANDAs from 171 ANDAs in the same quarter of

last year and 23 tentative approvals as compared to 43

tentative approvals.

Aurobindo Pharma has received the highest numbers of ANDA approvals among the Indian companies during the first quarter of 2018. It received 11 final ANDA approvals followed by Strides Shasun 6, Lupin 5, Cipla and Zydus Pharma 4 each, Dr Reddy's Laboratories, Hetero Labs and Taro Pharma 3 each. Macleods Pharma and Vivimed Global received 2 approval each. Alkem Laboratories, Gland Pharma, Glenmark Pharma, Granules India, Jubilant Life, Laurus Labs, Micro Labs and Torrent Pharma received one ANDA approval each in the first quarter. For the full year ended December 2017, Indian companies obtained 304 ANDA approvals out of 846 approvals by US FDA and 61 tentative approvals from 172 approvals. Among the Indian companies Zydus Pharma USA, received highest approvals of 66 ANDAs in 2017 followed by Aurobindo at 51 and Glenmark Pharma at 18. Leading Indian companies are investing huge amounts in R&D expenditure to meet international competition and filing new products in highly regulated market like US and Europe.

Lupin, Dr Reddy's Laboratories, Alkem Laboratories, Biocon, Cadila Healthcare, Sun Pharmaceuticals, Ajanta Pharma, etc, set to overcome competition in the international field. Lupin's aggregate revenue R&D expenditure during the first nine months ended December 2017 declined to Rs.1,450 crore from Rs.1,639 crore. Lupin filed 5 ANDA and received 6 approvals from the US FDA during the third quarter. Its cumulative ANDA filings with the US FDA stood at 382 as of December 31, 2017, with the company having received 231 approvals to date. The company now has 33 First-to-Files (FTF) filings including 16 exclusive FTF opportunities. Dr Reddy's Laboratories R&D expenditure declined to Rs.1,392 crore from Rs.1,497 crore during the nine months period ended December 2017. As at the end of December 2017, DRL's 102 generic filings were pending for approval with the US FDA (99 ANDAs and 3 NDAs). Alkem Laboratories' R&D expenditure increased to Rs.252.9 crore during first three quarter ended December 2017 from Rs.228.9 crore and worked out to 5.1 per cent of total

revenue. Thus, it filed total 96 ANDAs upto end of December 2017 of which 41 are Para IV filings including first-to-files. It received total approvals for 48 ANDAs. All the 6 manufacturing facilities catering to the US market have an EIR with no pending observations in any of them. Biocon's Research and Development expenses declined by 18 per cent to Rs.165 crore during first nine months ended December 2017 from Rs.201 crore. Cadila received approval for 24 new products for the US market from US FDA during the quarter ended December 2017 and filed 10 additional ANDAs with the US FDA. It launched 2 new products in the US during the quarter. Alembic Pharma's R&D expenditure declined to Rs.98 crore during third quarter ended December 2017 from Rs 121 crore in the last period. It received one ANDA approval during the December quarter and its cumulative total reached at 63 ANDA approvals. The company filed 4 ANDAs and its cumulative ANDA filings reached at 108 (119 with Orit acquisition.). It launched two new products in US.

Thus Indian companies are well set to grab future opportunities in the highly regulated market. Despite US FDA actions regarding quality during last couple of years, India pharma companies are well in a position to launch new products.

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